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Profissional Documentos
Cultura Documentos
Fernando and Jo/ui E Viteri, Svlvi A 32-mo-long, highland control sugar and three two communities, double-blind field community receiving vitamin Aand in the lowlands and study inonly vitaone The 17000. as was in the cornSugar retinyl well acon iron Edmundo Alvarez, Ramiro Batres, Benjamin Tor#{252}n, Oscar Pineda, Luis
iron
A MejIa,
shown
Guatemala Currently,
to be an adequate
(9), sugar and is being
vehicle
not fortified
for vitamin
impair with iron
A fortification
absorption A in Guate-
in
(10).
it does
FeNaEDIA-
vitamin
mala.
Consideration of the fortification of diets rich tion is essential. of this that meals of iron compound to be used in inhibitors of nonheme-iron in iron absorp-
highlands
ness fortified palmitate/kg cepted nutrition pregnant supplements of this munities
of Guatemala,
approach population with was
was
ranged
undertaken
iron and not 15 between 1200
to test
deficiency. and retinol and mg
the effective-
in controlling
the nonheme-iron
absorption demonstrated
A nonheme-iron compound becomes part of pool and its absorption is dictated by the iron pool. the the iron We and others sodium (1 1-13) previously in iron ethylenediaminotet-
segregate, impact
of fortification
at 8, 20, and 32 mo of intervention. All subjects with severe anemia received and were excluded in one from lowland the analysis.
raacetate
typical
(FeNaEDTA)
mixed
at food
fortification
described of iron. the total than when
levels
above
with
is ab-
characteristics
Iron
except
stores
for
in the fortified
women 18-48
communities
y of age
increased Iron
except 1995;61:1
significantly
community
forms it makes
An added nonheme-
iron pool,
that
in
including
that contributed
2.5 times
by food,
higher
as absorbable
a similar
as
and > 49 y in the control community among KEY adult WORDS field males.
highland
remained Am
community.
unchanged J Clin Nutr
stones
for 153-63.
in the
a rise
FeNaEDTA,
amount of iron as FeSO4 is added. A small pilot trial in the lowlands of Guatemala proved effective in preventing the recurrence of anemia in a semirural population (14). Fortification also South fed the of fish proven Africa doubly nutrients sauce and of curry powder effective in population trials (16). (17). Studies in vitamin sugar fortified demonstrated with FeNaEDTA in Thailand (15) iron-deficient the availability has
Iron,
trial,
vitamin
iron stores,
A, sugar,
Guatemala
FeNaEDTA,
double
fortification,
and
rats of
A and
both
is the most
2.5 billion ferropenic
common
people anemia
micronutnient
suffer and diminish from
deficiency
it (1). When with
is associated
poor
serious
health,
increased
risk
of maternal
that
peninatal
human
death,
and
The research objectives of the study being reported were to test the feasibility of the field application of doubly fortified with retinyl palmitate and FeNaEDTA, measure its effectiveness in controlling iron deficiency situations: 1) in highland populations where the almost
I
ment
developFrom the Department the Institute Guatemala Mexico; Supported RAMCO kits Nashua, used NH, used Nutritional March 24, and City, of Nutritional of Nutrition Guatemala; American DC. contract study, BASF, trial. Address correspondence of to FE Viteri, California, Berkeley, DepartCA University and AG, AIDITA-C-1341, prepared Hampshire Ludwigshafen, INCAP, and donated Chemical Germany, and PAHO/ the serum and the donated Co (Grace specially Sciences, of Central Kelloggs Health University America Latin and America, of California, Panama (INHealth Berkeley; CAP), Oro,
2
iron
chronic areas rare
intake,
(5-7). (5, 6)
America, iron deficiency and fenropenic anemia and severe especially among the lower-income (5, 6). This occurs mostly as a result of insufficient diets that impair iron absorption, multipanity, and
particularly hookworm in many lowland
Quer#{233}taro,
the Pan
Organization/World
infections,
the nutritional
widespread
little
to are
is
in children
FeNaEDTA
3 Reprints
not available.
A logical approach to control of iron deficiency and vitamin A deficiency is the fortification with iron and vitamin A of a food that reaches all the population groups at risk and fulfills the accepted criteria for a food vehicle (8). Sugar has been
Am i Cli,z Nuir
1995;61:1153-63.
ment 94720.
of
Sciences, 1994.
November
4, 1994.
Printed
in USA.
1995
American
Society
1153
1154 sive dietary mm sugar. cause of iron infected factor. A status of these deficiency with was hookworm, objective was receiving dietary, which and 2)
VITERI
in lowland the the vitafortified
El
AL
weighing derived
in dry milk)
corn and
husk
leaves;
they
are
populations
aggravated
tamales.)
orange, Each
A collateral
juices, milk
populations
on lemon)
of eight adult of rural origin. other characThey did were (T and insea
to note
Subjects All
Nutrition
and
teristic
of the foods and beverages not know which preparations had Field acceptability for this with study populations in sugar cane two
were
they had consumed. the fortified sugar. sugar. Four communities sites: two 38 possible
procedures were approved by INCAPs (the Institute of Central America and Panama) Committee for of Human and the in the us to take and operational offield of Subjects, oven the according Public management maintaining Health to the of the their Helsinki health usual Guatemalan communities, practices. application FeNaEDTAand retinyl palmitate-fortifled (Ingenio authorities,
chosen 12)
volved
Protection laration allowed that existed of care Feasibility Production sugar. Diego) already
delivering the
level),
and
(13
C) with
of
1645
in the
respectively,
in coffee
( 1100
pairs
profiles
were
m above sea level). These semirural matched as closely as possible socioeconomic from the Department after authorities and what several and was It was accept participation characteristics, of Public town leaders required clearly
individual
factory
in the lowlands
obtained involved
members
to add FeNaEDTA produced. Addition in a sweeping of refined added was to the sugar by each
community
all members
last
motion, the yellow sugar, while it still contained each fell into centrifuge drying did were sugar
understood decisions
that the researchnot to participate at any time, and that on the anemia,
humidity.
sured sugar
in the study
cup (adapted
discharged
load
centrifuge
would not carry any detriment. Participants, would benefit by learning whether they had they was would receive treatment. in a double-blind fashion. conducted
that carried and mixed the sugar to its final mixing stage before packaging. This procedure normal flow FeNaEDTA/kg vitamin A/kg of sugar sugar, production. providing sugar site, The goals 130 mg Fe/kg samples were
Community
unknown to everybody but to the first three In the original experimental design, a lowcommunity were to serve as controls to similar showed lowland
sugar.
Twelve
obtained
and a highland
tially at the packaging of five sugar batches determinations Stability conditions. that tion top. and Sugar
covering the production produced for the study. Iron at INCAP (18, of the fortified and packaging 19). sugar were
fortified communities. However, after the basal results a large discrepancy in iron nutrition between the two communities (T only community highland than the community latter did and 12) it was decided C as a control because
sugar for internal consumptwo-layered paper, sewn at the that helped disguise After production, was where transported the field the the to trials
(13) and differed less from community l from community 12, which showed unexpectsituation resulted in the favorable communities that differed in iron but weakened the design control was because cornto be
The sugar had slight added yellow (iron-fortified warehouses situated were
tropical
edly severe iron deficiency. This situation of having three fortified nutrition
there
from
severe
to mild,
sugar
near
was no negative lowland control. The single munity had an intermediate iron nutritional status. The supplied communities by us were to the local informed stores that where a new they sugar
to take
Pacific
would
normally
another one was located midway between the test communities in the Guatemalan highlands, 1080 m above sea level. These warehouses were chosen to represent the usual storage facilities used by
merchants in
purchase their sugar, that the price would be the same as ordinary sugar, and that it may or may not have added iron. We requested that all sugar purchases
in the
be made
in these
stores.
these and
communities.
Sugar
bags
were
stacked
To make
and retailers were asked we sold to keep
distributor
as possible,
under study sell the sugar They by
all sugar
distributors
usually
samples for iron and vitamin A analysis obtained periodically for up to 1 y, from the upper, middle, lower portions of 10 randomly chosen bags. Acceptability of commonly used food recipes prepared sugar and and included bread and corn fortified sugar. The added FeNaEDTA was detectable
sugars were placed next
done,
to only
supply of sugar
and
were contacted and we produced, which to do so and Each arrangement household. This
at a 15% store
containing unfortified common in unfortified various preparations, corn starch masa buns
had a very
clientele.
recipes
Any
about
each households or other comments were expected obtained subjects thus also noted. purchases exclusive be estimated
sugar purchases every received from their sugar purchases sugof the food-conbased on individual household consumption by household.
diets cookies of
prepared cakes,
Household
at INCAPs
experimental
compared
by periodic
chuchitos
(Dunyea)-based
FeNaEDTA-FORTIFIED As fortified
(eight for iron
SUGAR sugar and in the gathered analyzed laboratosugar as percent sugar operations also visited was of in the
IRON
STATUS 80 males
1155 18 y of age, 63 nonpregand 30 females 45 y of age. of obtaining end of the lon3 y in at the
of unfortified were reaction and with periodically coded, of the fortified expressed unfontified of field were at INCAPs
y of age,
communities,
18-44
were
y of age,
chosen on 163
all households,
in anticipation subjects
by a Prussian
information
ries. also
positive
fortified
communities
by the head
(EA)
stores.
and encouraged
Other households out
in
to consume
these control households. of iron
sugar
sold
at the community
each community, assuming a 20% dropout rate per year. The actual initial and final numbers studied and their age and sex distribution are presented in Table 1. In the group 9-17 y old the proportion of girls was near 70% in all communities at all evaluation periods. All subjects lost to follow-up had been
investigated nutritional tinuing in the in the When field in terms conditions study. trial possible, lasted of and with their with regard subjects 32 mo. 2. All set subject up hematological, regard did not to these were The to reasons differ encouraged time schedule from conditions iron, for and not (data to continue and the list those other conconnot
to avoid Effectiveness
singling
Dropouts
the
deficiency
>
tinuing invited and to particall individshown). The of are tices Quality procedures. present
All community
ipate in a fingertip uals with mild-moderate highland were treated lations who 67%, 54%, respectively.
members
basal values (defined
aged
hematocnit
I y were screening,
in the trials.
study procedures presented at INCAP controls Some paper are implemented in Table and were results the in the participating hematological both field paper and procedures not covered to follow. sugar is communities
indicative of anemia beyond a as a hematocnit < 30% in the in the lowland communities) popu62%, and C, screenproportions of the were as follows: T, 12, 13, least in the initial only found
or < 28%
conformed
for
to established
pracmethods.
to standardized of these
laboratory in the
of another
ing, particularly in community 13 where males were screened, none having been community numbers of 66% of children and women treated anemics in these 94, 12, severely
results (33),
under 20 g/L
at
esti-
subjects
respectively, 26, treated subjects, nant ness. each whose tological sample, women From
paper
children,
all of these
and of effectivemembers and adult
mated
to the The
iron stores,
based
body
on Cook
size of the
et als method
populations following: concentrations
adapted
study.
from
community,
men
and that
altitude cutoff,
were a deficit
considered of 0.238
and women
was
chosen
was
randomly
below the
among
-
hernatocnit
mg body
derived 70 mL
iron stores/kg
body
content wt.
wt was
assigned.
This
(3.4
figure
mg/g)
was
times
(20). in each
of hemoglobin
mean
more
hematocnit
than one
values
subject from
same
was
norms.
selected to undergo hematolog-
No
in
subjects with serum fennitin concentrations < 12 g!L, or with serum fennitin concentrations between 12 and 50 p.gfL and inadequate iron transport, the same index
defined estimated by Cook on the et al (33) basis was applied weight but (kg) iron stores were of body as follows:
2) For nonanemic
studies.
The
community
number
was
of subjects
as follows:
by
115
age
and
sex
1-8
sought
y of
children
in each age, 30
Iron stores
0.952
kg)
index
TABLE Number
1 of subjects involved in the study by sex and age groups Number in Basal 91 19 42 15 55 222 70 are higher than T1 Final 35
332
Number sought each Sex and age groups M and F (1-8 y) y) y) y) community 115 30 63 30 80 318 of expected number age and a proportion
-
examined
by community T, C Final 45 39 29 222 39 174 107 were Basal 103 32 60 30 68 293 92 32 mo older Final 50 46 29 29 35 189 116 at the final
T2 Basal 64
23
Final 27
272
20 12 27 127 78 those
15 10 27 106 65
F ( 45
M Total Percent
1 2
( 18 y)
sex categories
examination,
3
of the subjects
to a higher
age category.
Assuming
for each of 3 y.
1156
TABLE Schedule 2 of study, by month 0 Community involvement and actualization dietary record recall fecal test for sugar intake (Health of previous ova/parasites iron in sugar and distribution (24, 25) x
x (26-29)
VITERI
El
AL
10
12
14
16
18
20
22
24
26
28
30
32
34
36
38
40
42
Census
Individual Morbidity Morbidity
x
-
x x x x x x x
x
x x
x
x x
x x x x
xx
-x
x-
-x
x x
x x
x x
x x
x x
x
x x
x
of iron (30)
x x
x
x x
x
x x
x
copper,
Community
and debriefing
Inflammation
>
was recognized
presence occurred were
by a serum
ferritin
concentration
of anemia or defects in iron transonly seven times in this study and discarded.
tests effect
different (37).
basal
iron
stores
in isolating
the
subjects
children (4.5
with
adequate
the mo
iron transport
following of age
-
and
formu-
Results
Feasibility offield application
concentrations
12 p.gfL, 12-107
x kg)
x (ln SF
ln 12)
The produced
neous, being gression the very mean close was
FeNaEDTA-fortified
( SD) iron contents to the amount aimed also very stable except discoloration
sugar
was very
homoge-
and
ln is the natural logarithm and SF is serum ferritin in For females > 9 y old and males between the ages of 9 16 y 11 mo Iron stores
=
(124.3 18.8 mg/kg) for (130 mg/kg). This for a very slow prothat for conditions stored
preparation
of brownish conditions.
in extreme
(4.98
x (ln SF
ln 12)
was
severe
noticeable
to the eye
after
6 mo
sugar
of storage
is seldom
in the most
In Guatemala,
17 y of age
stores
(6.13
for iron
x kg)
stores,
x (ln SF
based
ln 12)
sex, and body and
tions
in tropical
algorithms
on age,
weight,
total body
were
iron
formulated
for both
from
sexes
literature
at different
values
ages
of normal
(34-36)
adapted for body weights so that when applied to the adult male and female populations reported by Cook et al (33) the values could be superimposed in the three conditions dictated by the
blood a smooth indicators transition of the body analysis four of iron between study iron status. These algorithms childrens also values allowed and those normal communities
used conn
hue objec-
of the blackened
tionable.
Light-color
Tea
baked
was
preparations
were
the
slightly
addition
darker,
of Fe-
acceptable.
for adults
dwellers tion of their
of the corresponding
stores.
sex.
Actual
were
body
used
weights
for estima-
of
sugar, similar to when the same amount of as FeSO4; however, in contrast with the latter
black color with the addition of lemon, it reverted to its in the case of tea with FeNaEDTA-fontified
Statistical
was NC)
sugar. Light coffee was slightly darkened also, but not objectionably so. The appearance of tea and coffee did not change with the addition of milk. In no case was taste, texture, or smell
altered.
concentrations,
transformations
Field
about control the
acceptability
expressed
as
number
of
complaints
in the There
households communities
tests
(SAS
linear with
analysis
of variance
Bonferronis covaniance
were eight individual complaints registered in 32 mo from households in community T1 and none from the other communities. These eight households frequently received sugar as
partial payment for work from a neighboring sugar mill. These,
SUGAR asked to
IMPROVES categories.
ries.
1157 categohouseholds
same
available individual of
with
as percent of expected sugar consumption sugar with This 104%, purchases the estimate and estimate based 92% expected provided for in
based on repeated estimates and household composition. each demand communities with community for sugar l, the compliance could by values each of also
Effectiveness
Table
values tion cohorts (32
4 presents
mo later) by age was
of
iron-nutni-
compared 98%,
indicators
it, by
of subjects
12,
13,
and
C,
was
respectively. Another obtained tests eight ance expected 93%, These community persistent indicated sugar one and times figures
casions. Final each subject were included between Despite presented excluded, pre-
the age and sex group Because clearly anemic low hemoglobin the differences concentrations and sex group concentrations all but with two the values makes
in the means.
in this
households
posthemoglobin
expressed
this, all but one age lower hemoglobin the basal finding evaluation and is compatible
12
positive was
T
tion.
in
in the higher
final basal
evaluapreva-
in communities
This
lence of severe anemia hemoglobin values were Mean cant) basal final hemoglobin
12. Also as expected, highland communities. in the majority (statistically signifilower relative mean In both Mean
> 45
concentrations
increased
>
of instances,
occurred values mean
but mean
only in the values
changes
in the two
run out of sugar, even though they stones. These cases were considered these estimates are compliance figures sugar purchases. of households had conservative estimated these or more in the same four tests from
bought their sugar from the negative tests. Therefore, and lower continuous tests than communitymonitoring 81%, and of 97%
lowland communities. approached normality. in which groups, females were high however,
instances the hemoglobin of age and examination. within between including and particuthan did the the the
Despite
difficulties, positive
79%,
values
in communities
l,
only ever. from were
and only
communities
18%,
14%,
and 2% had
A total of six positive
of total-iron-binding increased
communities. failed
evaluation
in all instances,
households
to test
These coincided with households the stores and were excluded from the lowland communities. average per capita amounts age and sex groups value is itself the
that made no purchases from the study. They all of sugar consumed in each
community C. Again, the lowland communities, larly community 12, presented lower basal values highland deficient transport fortified communities. In all instances, even lowland community, this biological approached communities normality exhibiting at the a greater end
The
In the lowland
communities
(T
free
erythroof a
values were elevated, Again, community improvements communities, the .agfL (> 700
greater deficiency. Significant were observed in the fortified instances mained in the lowland elevated abnormally
divided into highest, intermediate, ries, < 5% of all subjects always gory whereas 50-54% of subjects
communities
mean
red blood
fluctuated
between
the three
32 mo of fortification.
TABLE Amount
3 of sugar consumed per person in the study communities based on 1 1 individual measurements Community T1 1, T3 C2 in 36 mo
gld
Total Mean population by age and sex groups y) 35.5 39.5 36.8 were performed 42.5 before the 32 mo of intervention. 32.8 37.7 43.0 43.8 31.2
35.7
37.8
23.5
[246-27l]
37.3
20.6
[36()-412]
34.6
15.7
[338-400]
36.1
16.3 36.2
39.1
[204-239]
y)
35.0 40.6
36.4 39.5
per survey
in brackets.
1158
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FeNaEDTA-FORTIFIED
Serum the lowland had depleted The fortified fication. fenritin iron changes values demonstrated including As responded in ferritin two upward) communities. adult with very were the that a large men other positively small proportion indicators, to iron in community compared
SUGAR
of 12, the fortiC with
IMPROVES
IRON
STATUS
I 159
in community
concentration
E
U)
( one
those
Lu
In summary, with few exceptions, when they were lower to begin with
were clearly demonstrated tons of iron community good at basal evaluation subjects. remarkable status C showed within very after Overall, improvements the little 32 anemic
values overall
communities
nose they
of the indica-
0 I-
U)
removal
z
0
contrast, to note
BI2F CHILDREN
I-lly
that in all the communities there ment in hemoglobin concentration lower however, values were at the beginning There only significant.
the also
study.
BI2F FEMALES 45 y
SI MALES i8 y
1. Evolution
periods
iron
stores C (0)
grouped
of regression
comparisons
to the mean,
were made
particularly
in community
13. When
and the
evaluation
32 mo of iron
fortification
(#{149}), and
B, basal after
T3 (A). evaluation
communities (C and 13) that started the study status, differences in final values favored the on the study. of age lowest Women children the are basal To and in of
mo of intervention;
2, evaluation 32 mo of except
and F, final
intervention.
latter, particularly for serum ferritin concentrations. Means and SDs of individual iron stores estimated basis also iron and begin small except women values. basal of the presented status the with, children changes iron and above of the indicators age stores community and age consistently had lower and sex and by reflect status age and even in the during They with than sex better four in terms were age. older the groups, in Table observed 4. These in iron
are significant
groups
communities
cation slower
It must
and in general, with time, mean rates of change as iron deficiency disappears and stores become be realized whereas that due that positive iron values hemoglobin stones reflect (> an values. determined to have less be expressed 0) represent iron negative to reduced
behaved
deficit,
characteristics.
(a
that iron reserves are greatly child would be expected grown adult), they can
in community C. Iron stores were higher in older and in adult men, who, in general, exhibited the highest As seen before, the lowland communities had lower iron stores for the same and age and sex groups were, than those of communities, all the groups on average,
than
a fully
the highland
to generate under
12. Increments
communities
in iron stores
in all but two age
were
and
By expressing negative
as a percent iron
sex groups,
and remained
static
in community
C, except
for the
was controlled
adult males, who increment did not same iron group stores
increased their iron stores differ (P > 0.07) from that 13. sequential instances changes when and
with time. This registered for the observed in mean was and 32
Figure
programmed:
1 depicts
in
and are expressed also as percentile units of the norm. Therefore, 100% represents an iron deficit of the same magnitude
-
as total with
the
expected community, as
for even
that by Figure
This in the
blood
sampling at 8, 20,
allows
expression populations
as weighted
intervention)
The data include only the cohort information was available in each
and 132 subjects for communities
subjects sampling
T, 12,
a whole.
basal and final results of this mode of expression, reflects the norm, 0% indicates no iron reserves, values reflect iron reserves. iron deficiencies as percents The effect of sugar fortification
13, and C, respectively. In other words, they constitute 70%, 70%, 88%, and 70% ofthe cohort with complete basal and final values in the respective communities. For this reason, the two groups subset groups, of children of subjects, were none for women stores. and magnitude revealing. more of the response The fastest and deficient groups to iron highest at the start fortification increments of fortificombined of the groups into a single in community group. In this C showed
as well as the stability Covariance analysis were controlled for changes relation in iron stores to community
of community C are evident. (data not shown) in which basal demonstrated occurred C. The that significant in each fortified fortified communities
a significant
except in iron
change women
in iron
stores
whereas
age
fortified
T
of reproductive
in community
community in as a group
and older
ments The shape is particularly occur
in community
13, showed
incre-
were
lute
also
as well
different
results
from
the control
iron including and urinary
community
store values. detailed mineral
in both
data
abso-
on anemia morbidity,
nontreated trace
groups,
among
the
intake,
concentrations,
1160
150
VITERI
El
AL
100
>
Lu
NS
U)
Lu
50
NS4
174NS f
KS MANS
2/s
z
0
a!
I-
-50
ULu
z
0
B 18-44 F as percent
B 45 F norm
127),
B 18 N
B ALL ALL
of individual T1
J,
grouped T2
population
All
(all) from
(0, n
ALL,
(#{149}, n =
intervention;
n =
179).
changes
by NS. B, basal
evaluation
before .t SD.
evaluation
after
32 mo
of intervention;
as a whole.
vitamin studied
A are
and
parasite
the
subjects
did great
not
differ.
no
in
the The to
of another
preparation).
discontinuation majority fecal in economically jects in the the cohort reduces groups Despite
to the
Suffice
ularly
it to state
community
lowland infection
of these
communities, than
variables
household
exhibited
blood
loss
due
The reduced number final evaluation, and four periodic differences evaluation
communities,
in the
evaluations,
are clear
of the fortified
population
Discussion
This liminany among where iron-fortification steps to the low-income, iron deficiency study implementation included testing of a field a series trial of pre-
a preventive
rather
than a therapeutic measure for iron deficiency, and for ethical reasons, any individual with moderate or severe anemia (hematocrit was usually personnel. during given
< 30%
conducted
in the in the
<
and
the
32-mo
were
field
trial
itself.
in the
Both
field
highland
trial
and
the
lowland
effec-
as
populations
included
to test
the 32-mo
included individuals
As a consequence
of excluding
ferropenic
bin values, the sensitivity of hemoglobin response to fortification was markedly reduced. In effect, only 20 of a total cohort
of 596 sample in subjects (3.3% had hemoglobin values
<
ful in proving
of execution,
vitamin
the feasibility, organoleptic advantages, simplicand biological effectiveness of FeNaEDTAsugar in controlling iron deficiency
100
gIL
in the basal
prevalence).
Of these,
19 resided
in the lowlands,
and
A-fortified Guatemala.
6 were
children
between
1 and
8 y of age,
and 5 were
adult
semirural
The
could issues
field
trial
was
not
without
problems,
some
of which
Four main
males in community 12. At the final evaluation, 13 subjects had hemoglobin concentrations < 100 g/L (2.2% prevalence). Twelve of these resided in the lowlands and five of them were
invalidate in this
obtained.
children
time could be if there was a
between
1 and 8 y of age.
to this before, Because in the for the lowland other.
Two
adult
males
1) The responsible
natural
erentially
munity 12 belonged 3) As indicated called one serve nutritional for in the two status control lowlands.
selection
process situation
analysis
that excluded
subjects in the
from
fortified
follow-up
communities.
pref-
communities,
iron-deficient on extensive
The
based
confounding
can
be rejected
with
and
confidence
socioeco-
communities, time
as a control
effort already invested when the disparity became impractical to seek a third lowland community.
FeNaEDTA-FORTIFIED
the control and community biology showed during a remarkable stability while
SUGAR
in iron the three
IMPROVES
explanations. cation consumed of the improbable
IRON
The sugar
because
STATUS
possibility in this sugar for trial not (data include highlands vitamin and of an effect all other with years shown). who 28% in had the fortified several A deficiency not or subjects
<
1161 of vitamin communities vitamin before in plasma this A fortifiis highly A was trial samples hematocnit lowlands, being and at
nutrition
the 32 mo of study,
fortified communities, including a similar (13), showed a significant improvement makes us confident of the results sugar exclusively near men sugar-cane in these imperfect design. 4) Infiltration nities nities that was (T employed detected and 12), most
highland community in the same indicators even fortified lowland with this
we any
the
commucommuand mills During could practice in the on less were A sold. Based
in the
values
30%
in the
plantations communities.
close to 95 and 90 before the final details of these to be considered it to say that with new eight cases of time were which treated lower than new in
sugar-production receive some was reduced intervention household than expected to encouraged
qualitative
periods (-4 mo of the year) employees sugar at the mills as pay in kind. This when period, sugar-purchase and receiving exchange the but mills did were not sugar this approached fully directly for disappear. those from that early purchasing
of more in
monitoring, sugar
intervention,
reinforce basis of
in sugar was also introduced to The end result was that on the and
>
and
purchases sugar
77% time,
> 90%
of
C (28.9%). in community
consumed
fortified
the results fortification criteria
sugar
of this with of the
and of the
C (27.2%)
these
study World
a much greater hookworm infestation and a precarious nutritional status before fortification. The more important results, given the preventive approach the trial, nutrition community munity by
rnunity.
strate
the
effectiveness
FeNaEDTA.
If anemia
Organization hemoglobin in the communities: community in community among
is estimated
the biological aspects of iron As was evident in Table 4, the by most the iron-deficient other lowland had start with give strong very of the those support of iron similar trial. expected corncorniron The by to the stones
for altitude (highland by 5 g/L), there was anemia prevalence in both of a basal
12 was consistently all indicators, followed two were by age highland less and deficient in iron sex and groups
prevalence T,
mild-moderate from
13.9%
from
a basal
prevalence
occurred and adult
of 41.7%
primarily men in
in prevalence
young
> 45 y of age
in the estimations
community T, and among all age and sex groups in community 12. There was also a 2.6% decline in anemia prevalence in the highland community (13), from a basal prevalence of 10.2% showed tion to of 8.7%. a final These prevalence in prevalence reductions of 7.6%. 13.9% Community to C also a decline from
relative iron reserves and sex categories. with time of relative expectations. this field as each in some populations is greatly
despite small numbers in some of the Moreover, the sequence of change depicted reserves show shown the clear in Figure in Figure tendency levels and equilibrium to be l the and degree 1 and the iron trial 2 agree of iron
observed characteristics
of fortification
5.2%,
except
a reducfor those
are significant
with biological Results from stores suggesting status among new needs most reached. the to
characteristic
in community 13. The reduction in anemia prevalence in the lowland communities was also significantly greater than that in community C (P < 0.05). Given the sample structure of the
trial, sugar even these among results are with populations as high encouraging FeNaEDTA with overall and support the efficacy nutrition anemia of fortification in improving mild-moderate iron
they age in 32
that appear community, in iron the 13. case This will is The
situations
is approached equilibrium
of iron
prevalence
as 41.7%.
At final
evaluation
66 subjects
Of these, at the
had hemoglobin
values
below
losses). Iron stones until this equilibrium of community in response in communities 12. are that reserves
of these were lowland residents and of them two women of reproductive age, one woman men. 13: In two
were y of
implications of this phenomenon fication programs, iron stores and poor diets and large values than desirable environmental iron reserves that will probably health, among losses until and women
to fontiwith
age, and five adult resided in community age, male one adult woman adults, whereas resided
the highland communities, subjects between 9 and sex category, in each age
will take longer to stabilize at lower losses are reduced (deparasitization, birth spacing). The ideal age of bringing to an amount will most in the develof reproductive
category concentrations
We have
in community C. no explanation for the improvement in community C. We could claim efficiency treatment in health of anemia these
in hemoglobin regression to care (under our in all the commuare only possible
oping world. This tive supplementation same time, under iron are overload minuscule. Five
probably be achieved only by prevenof this vulnerable group (8, 39). At the these circumstances the risks of producing of iron-fortification and six cases programs at end evalucases at basal
as a consequence
including
the
control.
However,
1162
ations which with
oratory by
El
AL grammes that the present fication clusions and additive sodium tentative and iron that The Committee prepared when used provisionally at the meeting concluded meeting does food not forti-
>
women
all
of age lab-
EDIA problem
(ethylenediaminotetraacetate) in supervised
serum
ferritin of iron
concentrations The
specifications
of cases
age and sex groups and serum ferritin concentrations these The cases suggest an artifact of response magnitudes
in iron deficient populations. on exhaustive tests in experimental essentially range show of doses. that Acute EDIA and chronic
humans, over
which a wide
agree with expectations in that community 12 had the greatest response whereas community 13 had the smallest one, in direct proportion covaniance to initial analysis iron not degree of the of iron deficiency. to fortification, for, indicate start of the on iron Results with from difresponse
occurs with doses that used in iron-fortification daily intake (ADI) for fortification even safe The trials
cultural-grade
makes
ferences in basal iron stores were fortification had even, these increased munities, especially tion.
growth.
at the amounts used in this trial consuming 30 g fortified sugan/d. conducted that were with batches of agniand of bacteniologically
an insignificant
reserves.
and only in the fortified cornwere negative before fortificaincrements in keeping with in iron their reserves physical
chemically Results of
Also,
in the
groups
of children
EDIA
compared complete humans. Given
as a food
with safety these
additive
industrially in the use
in semi-rural
advanced of
Guaternalan
countries
diets
indicate sugar organoleptic
as
the
in the fortified accomplishing populations tional status At the same load. The
trative mality
communities
In other
studied:
words,
exactly
sugar
what
fortified
hoped bringing
with
normality
FeNaEDTA
to iron
was
in the nutni-
by
to accomplish
it was
of FeNaEDTA, its ease in handling its proven efficacy as an iron source A and iron) even under low risk FeNaEDTA other be
in in
results in that
doubly fortified nutritional status conditions, load sidered As in with grams, should samples overload mote. and in iron-deficient an excellent all
sugar (vitamin of populations the extremely populations, choice and monitoring should
to improve iron very unfavorable iron overbe con(41). proof changes monitoring should programs and This
as a whole
of inducing
in the final
evaluation
86% of the norm. The distribution males in this community can mated from Cook body et als size data the smaller
in adult that estifor population age and of adult in sugar (6). The In prevaand at the end
fortification status
nutrition-intervention
for adult
adjusted
a systematic
of the Guatemalan
nutritional
of that community. sex group conform males in the US Survey, and iron nutrition among low of the contrast, lence were men overall trial
This suggests that the data to that for iron nutritional National Health and Nutrition
fernitin determinations in well-defined to prevent any long-term risk of iron at present this effect appears with very re-
Examination normality
that, taking that can be achieved even supports when the iron prevalence
as the norm, complete with FeNaEDTA-fortified of their in that C had were only diet of this the 42% community same
is poor
FeNaEDIA for the control years of may of its iron actuof supple-
of iron
mentation
deficiency and
a few costs
normality
establishment
though
control world
members their
Consultative for
be
by
a factorial
Bulux
critical
his technical
help, manuscript.
to Samuel expressed We
study
where from
requirements, and
are also
the 32 rno of fortification, changes iron in iron absorption figures for mean
are deeply
communities
indebted
hookworm,
and Community
of the
authorities with
estimates
to the
members
for different
communities
range
from
ing, lowing
the
field
personnel. Guatemala)
0.95 to 3.06 rng Fe/d, or 3.5-14.1% within the range of absorption double-isotope Guaternalan
nities,
of total iron intake, values obtained in previously consumed conducted by these sugar are in line with
decided
of Ingenio
(Escuintla, possible.
of vitamin studies
A and FeNaEDTA-fortified
and -unfortified
with
FeNaEDTA-fortified reserves
(11).
possible
References
1.
Organization. 89th
strategies of the
microGeneva: con-
FAO/WHO Expert Committee on Food (40) concluded that FeNaEDTA is provito be safe in food fortification pro-
malnutrition.
Executive hunger.
2.
Viteri
deficiency.
Ending
hidden
A policy
FeNaEDTA-FORTIFIED
ference Child ville,
4.
SUGAR
Task Force for
IMPROVES
dietary mala).
22.
IRON
intake Trop
STATUS
two methods (San Antonio A, Klein J Trop Ia Paz,
I 163
Guate-
on Survival
Atlanta: 1992:145-84.
The
and Development, ed. Functional for Nutrition, The Technol deficiencies. Advisory challengc status Committee de Salud evaluation
1965;17:135-45. C, Lechtig surveys. R. UnderreEnviron ed. New morbidity Introduction Inc, 1955. in Haematology. blood. Lewis Academic in blood iron plasma binding Recomin human of the PCV. London: of iron of total In: Br J Haematol SM, Coster Press, JF, 1975: Pediatr 10th
3. Enwonwu
TN: Scrimshaw industry. 5. Viteri iron 6. FE. and
of iron Medical
Nashfood
global
Food folate
1993;47:6()-71. of the Central DC: on Medical de los paIses of the population Institute (in Mata U. of Nutrition Nutritional (Anemias population: Health America America Am#{233}rAmerica y Washington, Pan American 1973.
23.
Chandler York:
Hematological
24.
International Committee
mendations 1967; 13(suppl):71-5.
for Standardization
haemoglobinometry appraisal
25.
I. Critical control
de la poblaci#{243}n de Centro
in haematology.
Panama.) FE,
and Panama
26.
Ramsay Clin Chim Ramsay serum. Heller whole Ramco. Co. Herbert activity Anderson vitamin
or serum. capacity of in
of hookworm
27.
Acta Chem
28.
RF, Nutter
J. A simplified kit.
assay
Clin
Foundation, level.
ferritin
M, Guzm#{225}nMA. 1979.
addition serum.
for Lactobacillus l966;19:12-4. method and zinc MG. CA. for Euglena copper Pathol Blood
casei of folate
assay of the
M, Velez J Clin
FE, GarcIa-Iba#{241}ez R, Tor#{252}n B. Sodium fortification J Clin Am Nutr J Clin AP, RW. FE, Monroe Quebec, Mcd DE, compound 1978;31:961-71. C. Fe(III)EDTA 1977;30:1166-74. TB, Torrance the in Central America.
l964;17:14-26. levels Estimates Clinical UK: in various of iron 1970;54:570-7. 1986;68:726-31. estimation Blackwell of measureIn: London: L, Oxford, Methods deficiency.
iron Am
12.
Sinha
Cook
pathologic
33.
complex
as iron
sufficiency 34. Bothwell of body Scientific 35. Heinrich ment, Hallberg Academic 36. Saddi Harwerth Press,
37.
13.
affecting
198 l;45:215-27. deficiency NaFeEDTA. Nutrition Am in Thai TH, Gillooly Med fish M, trial. between in Central In: White Congress Assoc, sauce. Mayet Am (5th 1978. Ann FG. J Clin
38.
Publications, relationship,
therapeutic
applications.
Hemisphere in transition.
L, Harwerth Press, HG, R, Schapira 1970:183-98. Analysis NC: SAS FE. A guide
Canada).
1970:213-96. G. Iron Vanotti growth. In: Hallberg Academic statistics. anemias 5th and London: guide:
16.
Institute. Inc,
1980;49:162-9. 0, FE. Interactions nutrients. palmitate nutrientes Guatemala and Panama Cook Iron JD, vitamin of both en ambos fortificada Guatemala: CA. A and nutrients in rats deficient Bioavailability and NaFeEDTA. en azucar City, Finch
the global
to Nutrition
39.
Viteri iron
A. Absorption
en ratas deficientes
Biodisponibilidad de retinol TH, iron OH, Chem and Nutrition Bothwell tissue Blackwell 19. Lowry tometer J Biol
20.
(Annual
of Central
WHO-FAO. (JECFA). INACG. The Kaltwasser overload. Levin eds. Oxford HM, Disease
Committee WHO,
metabolism 1979:443-fl.
Washington,
Nutrition
adaptation
spectrophomaterials.
evaluation
on minute
quantities Normal
1946;163:633-42. V, Guzm#{225}nMA. population. Z, Lara MY. values and mothers in American Flores Br J Haematol Estimation 1972;23:189-204.
43.
Viteri Flores
FE, de Tuna M,
disorders.
the Central
21.