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2 Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853; 3 Food Consumption and Nutrition Division, International Food Policy Research Institute, Washington, DC 20006; 4 International Potato Center (CIP-SSA), Kampala, Uganda; and 5 World Vision, Juvenat, Port au Prince, Haiti
* To whom correspondence should be addressed. E-mail: pm38{at}cornell.edu.
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ABSTRACT |
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 TOP ABSTRACT IntroductionEvaluation Design and MethodsResultsDiscussionLITERATURE CITED |
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Introduction |
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TOPABSTRACTIntroductionEvaluation Design and MethodsResultsDiscussionLITERATURE CITED |
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In Haiti, more than one-half of rural children under the age of 2 y are anemic [hemoglobin (Hb)6 < 100 g/L] (5). In previous work in Haiti, we documented that iron-fortified, donated food commodities [wheat-soy blend (WSB) or corn-soy blend]7 could not provide sufficient iron to meet the iron needs of infants participating in a maternal and child health and nutrition (MCHN) program, even when combined with heme iron-rich, locally available foods such as meat or organ meats (6). These findings highlighted the need to identify and evaluate new solutions to address iron-deficiency anemia in this population, such as micronutrient Sprinkles.
The objective of this research was to assess the effectiveness of an intervention providing 2 mo of micronutrient Sprinkles (containing 12.5 mg iron and other key micronutrients) in reducing anemia among children 9–24 mo of age in rural Haiti. Separately, we also assessed the feasibility of integrating this intervention into the existing MCHN program system (7).
Our primary hypothesis was that a 2-mo supply of micronutrient Sprinkles, when provided along with fortified WSB rations and with specific behavior change communication on appropriate use of the Sprinkles, would be effective in increasing Hb levels and reducing the prevalence of anemia in children 9- to 24-mo old. Based on previous research findings, we also hypothesized that greater impacts would be seen among younger compared with older infants and among infants who were anemic at baseline compared with nonanemic infants (8).
Setting and programmatic context. The evaluation was conducted in the Central Plateau region of Haiti, where World Vision (WV)-Haiti has been active for several years. The WV program offers services at 5 contact points between program staff and beneficiaries. These include 1) rally posts, where health education, growth monitoring and promotion, and preventive health care are provided and program beneficiaries are identified; 2) mothers' clubs, in which small groups of beneficiaries and WV health staff gather to discuss health, hygiene, and nutrition topics in the context of the program's behavior change and communication (BCC) strategy; 3) pre- and postnatal consultations, where pregnant and lactating women receive preventive health care and education; 4) food distribution points (FDP), where program beneficiaries receive their monthly food rations; and 5) home visits, where WV health staff visit beneficiary households with a newborn infant, a severely malnourished child, or a child with faltering growth.
The Sprinkles intervention. The Sprinkles intervention included 2 components: a 2-mo supply of Sprinkles and a BCC intervention, which conveyed information on appropriate use of the Sprinkles. The choice of a 2-mo duration was based on previous research that showed a 60-sachet Sprinkles regimen was efficacious in reducing anemia (1,2), albeit with higher doses of Fe than in this study, and current recommendations from the Sprinkles Global Health Initiative for using Sprinkles (http://sghi.org/about_sprinkles/recommend_use.html).
The Sprinkles were distributed 1x/mo along with the fortified WSB for 2 consecutive months. Each month, mothers received 2 resealable plastic packages, each containing 15 sachets of Sprinkles and a pictorial instruction sheet on appropriate use of the Sprinkles. Each Sprinkles sachet contained 12.5 mg of iron, 5 mg zinc, 400 µg vitamin A, 160 µg folic acid, and 30 mg vitamin C (manufactured and packaged by Ped-Med Limited). The monthly fortified food ration included a direct ration (for the beneficiary child) of 8 kg of fortified WSB and 2.5 kg oil (vitamin A fortified) and an indirect ration for the beneficiary child's household, which provided 10 kg soy-fortified bulgur and 2.5 kg brown lentils. The total cost of the 2-mo Sprinkles supply was $2 US.
Mothers of beneficiary children received special instructions on the use of the Sprinkles at their scheduled monthly education session at the mothers' club, 1 mo before they started receiving the Sprinkles. Health workers also reminded mothers about the appropriate use of the Sprinkles when they distributed them at the FDP. The instructions in each package reinforced the messages.
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Evaluation Design and Methods |
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TOPABSTRACTIntroductionEvaluation Design and MethodsResultsDiscussionLITERATURE CITED |
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Randomization. The Sprinkles intervention was randomly allocated at the level of the FDP, because the Sprinkles were to be distributed at the FDP along with food rations. Of the 10 FDP included in the study, 6 FDP were randomly allocated to the S-WSB group and 4 FDP to the WSB group. Within these FDP, 468 children were assessed for eligibility; 43 were excluded because they were: 1) severely anemic (Hb < 70 g/L) (n = 3); 2) not receiving WSB (n = 36); or 3) not accompanied by their mother (n = 13). Children identified as severely anemic at baseline were referred to the local hospital for further follow-up and treatment. We had no refusals.
Sample size estimation.
A sample size of 107 children was determined to be adequate to detect a reduction in the prevalence of low Hb (<100 g/L) from 50 to 30% and an increase in mean Hb from baseline to follow-up of 0.5 g/L with power of 0.9 and an 
level of 0.05 (9). The sample size was inflated to 250 to account for clustering within FDP, proportion of anemia attributable to iron deficiency (10), and loss to follow-up. Only 150 children were included in the WSB group because of funding and logistical constraints.
Timing of assessments. The baseline assessment was conducted in March–April 2005, the Sprinkles distribution in June and July 2005, and the 1st follow-up in August and September 2005, i.e. at least 2 mo after the Sprinkles were first distributed to beneficiary children and 1 to 5 wk after the last sachet from the 2-mo Sprinkles supply should have been consumed by the child. The delay between the baseline assessment and the Sprinkles distribution was due to problems with the Sprinkles manufacturing process, whereas variability in the duration between the last distribution of Sprinkles and the 1st follow-up was due to WV's monthly scheduling of rally posts; both of these were outside the research team's control.
A 2nd follow-up assessment of the S-WSB group was conducted in March 2006, 
9 mo after the children first received Sprinkles. The assessment was not done among the WSB group, because, by design, these children received Sprinkles at the end of the 1st 2-mo follow-up.
Child age at baseline, intervention, and follow-up assessments. This study was originally designed to target children 6- to 21-mo old. However, because the Sprinkles intervention started 3 mo after baseline measurements were taken, children received the intervention when they were 9- to 24-mo old and, thus, they were 12- to 27-mo old at the 1st follow-up and 18- to 33-mo old at the 2nd follow-up.
Data collected. Hb assessments and anthropometric measurements were done at baseline and at 2 and 9 mo (the latter only for the S-WSB group) after the start of the intervention. Hb assessments were done using the Hemocue method (11) by WV nurses who were trained and standardized to reduce inter- and intra-measurer variability, prior to each data collection using recommended standardization protocols (12). Weight was measured using a UNICEF Seca scale (SECA) accurate to 0.1 kg and height was measured using wooden length boards accurate to 1 mm (Irwin Shorr Productions). Weight and length were measured by 2 survey fieldworkers who were standardized using recommended protocols (13).
The baseline and 1st follow-up gathered recall information on child feeding practices in the previous 24 h, consumption of WSB, animal source foods, and other iron-containing preparations. Additional data were gathered at the 1st follow-up on reported consumption of Sprinkles, maternal knowledge and reported use of Sprinkles for the target child, and indicators of household socioeconomic status (e.g. ownership of domestic assets, productive assets, and livestock). Data on morbidity symptoms in the previous 24 h and 2 wk and hospitalizations or doctor visits during the 2 mo preceding the morbidity recall were gathered at baseline and 1st follow-up and during the 1st and 2nd mo of Sprinkles distribution. A home visit was conducted by a WV employee 6–8 wk after the children received Sprinkles for the first time to verify compliance.
At the 2nd follow-up, Hb assessments were conducted and data were gathered on Sprinkles receipt or purchase in the period between the 1st and 2nd follow-up, either through the WV program or through purchase of commercially marketed Sprinkles (which were available in Haiti since November 2005).
Statistical methods.
Data were entered using Epi-Info 6 (CDC) and were analyzed using SPSS 13.0 (SPSS) and Stata 9.0 (StataCorp) All analyses were conducted on an intent-to-treat basis. We tested the significance of the change within groups in the prevalence of anemia between baseline and follow-up using a McNemar's test and a Z-test using the chi-square statistics from the McNemar's test to assess the significance of the difference between treatment groups in changes from baseline to follow-up. We used a t test to examine the significance of the mean change in Hb at the level of the FDP (the unit of randomization). In subsequent analyses, individual level data were used and random effects regression approaches (xtreg and xtlogit procedures in Stata 9.0) were used to account for clustering of errors at the FDP level and to adjust for child age, sex, and baseline Hb. An of P < 0.05 was used to assess significance. We included interaction terms in 2 separate models to test our a priori hypotheses of greater impact among younger children and among children who were anemic at baseline. Following the xtreg and xtlogit procedures in Stata, we used the adjust option in Stata to derive adjusted means for the S-WSB and WSB groups. In doing so, we allowed baseline Hb/baseline anemia to vary within group so as to address the differential regression to the mean in the 2 groups (due to different initial Hb means and anemia rates). This method provides a more conservative estimate than holding baseline Hb constant across the 2 groups.
Ethical approval. Approval for the study was obtained from the Cornell University Committee on Human Subjects, the office of Coordination of the National Nutrition Program (situated within the Ministry of Health) in Haiti, and WV-Haiti. All mothers of study children were provided with detailed information about the study in writing and verbally at recruitment and they all gave informed consent.
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Results |
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TOPABSTRACTIntroductionEvaluation Design and MethodsResultsDiscussionLITERATURE CITED |
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2 mo younger than those lost to follow-up (P < 0.001; t test) but was similar in all other child, maternal, and household characteristics.
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In interviews with mothers, 62% reported feeding Sprinkles to their child every day during the previous week and another 25% reported giving them between 4–6 d/wk. Over 95% of mothers reported that they used an entire sachet of Sprinkles each time, they mixed Sprinkles into solid or semisolid foods, as recommended, and the child consumed all the food the Sprinkles were mixed into.
Estimated quantity of Sprinkles consumed. Using data on sachets remaining at home at 1st follow-up, we estimated a mean consumption of 57.6 (of the planned 60) sachets (4.9 SD; range, 27–60). None of the children had received additional Sprinkles from the WV program in the period between the 1st and 2nd follow-up assessments, nor did their mothers report purchasing commercially available Sprinkles during this period.
Consumption of iron-fortified WSB and animal flesh foods. Consumption of WSB and animal flesh foods was comparable at baseline for both groups. More than 70% of mothers reported having fed their child WSB in the previous 24 h and 97% in the previous 7 d.
Impact of Sprinkles on changes in anemia and mean Hb. Using unadjusted prevalences of anemia, the results show a drop from 52.3% at baseline to 28.3% at 1st follow-up in the S-WSB group (P < 0.001; McNemar's test) compared with an increase from 37 to 45% in the WSB group (P = 0.07) (Table 2). The adjusted prevalences show a similar pattern; baseline (adjusted for age and sex) and final (adjusted for baseline prevalence, age, and sex) prevalences show a drop from 53.7 to 24.5% in the S-WSB group and an increase from 39.4 to 43.3% in the WSB group. Thus, compared with the WSB group, the reduction in anemia prevalence from baseline to 1st follow-up in the S-WSB group was 33.1 percentage points larger.
At 2nd follow-up, anemia in the S-WSB group (adjusted for age and sex) had dropped further to 14.3% (P < 0.001), showing an overall drop in anemia prevalence from baseline to 2nd follow-up in the S-WSB group of 39.4 percentage points.
Recovery from anemia at the 1st follow-up was twice as high in the S-WSB group compared with the WSB group (56 vs. 27%; P < 0.05). Similarly, the proportion of nonanemic children who became anemic over the 2-mo period was about twice as large in the WSB group compared with the S-WSB group (29 vs. 11%; P < 0.05). At the 2nd follow-up, 76% of the children who were anemic at baseline and received the Sprinkles had recovered from anemia and 92% of children who were nonanemic at the 1st follow-up remained nonanemic.
Mean changes in Hb between baseline and 1st follow-up differed between treatment groups (using FDP level means) (P < 0.001); mean Hb (using individual level data and adjusted for child age, sex. and initial Hb) increased by 5.5 g/L in the S-WSB group (P < 0.001) and declined by 1.0 g/L in the WSB group (P < 0.001) at 1st follow-up. Mean Hb (adjusted for child age, sex, and initial Hb) increased by 10.9 g/L between baseline and the 2nd follow-up in the S-WSB group (P < 0.001).
Multivariate analyses. The main effects regression model in Table 3 confirms that the S-WSB group had a significantly higher mean Hb at 1st follow-up when controlling for age, gender, and baseline Hb (column A in Table 3). The mean adjusted difference between groups at 1st follow up was 3.9 g/L. The impact of Sprinkles on mean Hb was larger among younger age groups (6–17.9 mo) compared with older children (18–21.9 mo) at baseline8 (column B in Table 3; Fig. 2). The mean adjusted Hb at 1st follow-up among children <18 mo old at baseline was 6.0 g/L larger in the S-WSB group compared with the WSB group, whereas differences between groups were only 0.8 g/L among children who were older at baseline.
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Morbidity symptoms. With minor exceptions, the prevalence of morbidity symptoms was similar between the groups at all 4 morbidity assessments. The S-WSB group had a higher prevalence of cough at baseline but not thereafter. Excessive fussing and doctor visits were lower (P < 0.05) in the S-WSB group during the 1st mo of Sprinkles distribution.
The prevalence of diarrhea among nonanemic children tended to increase between baseline and the 1st-mo morbidity assessment in the S-WSB group (P = 0.13) and diarrhea was more prevalent among the S-WSB group (58%) compared with the WSB group (43%) during the 1st mo of Sprinkles distribution (P < 0.05), but not thereafter. S-WSB and WSB groups in the nonanemic group did not differ.
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Discussion |
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TOPABSTRACTIntroductionEvaluation Design and MethodsResultsDiscussionLITERATURE CITED |
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7 mo after the intervention ended showed that anemia rates were further reduced to 14% among children in the S-WSB group. Rates of recovery from anemia among the group who received Sprinkles were double those of the WSB group at the end of the 2-mo intervention (1st follow-up; 56 vs. 27%). Moreover, 7 mo later and without any further Sprinkles consumption, more than three-quarters (76%) of children in the S-WSB group had recovered from anemia since baseline and 92% of those who were nonanemic children at the end of the intervention (1st follow-up) were still nonanemic.
Notably, close to one-half (46%) of the children in our sample were anemic at baseline despite receiving iron-fortified WSB for a mean of 5 mo. Although we cannot estimate the contribution of WSB to anemia prevention due to lack of a control group, the prevalence of severe anemia (Hb <7g/L) was extremely low (0.7%). This may be due to the consumption of fortified WSB.
The magnitude of impact on anemia reduction (56% at 2 mo, 74% at 9 mo) and recovery from anemia (56% at 2 mo, 76% at 9 mo) in this Sprinkles effectiveness study is comparable to that seen in efficacy trials conducted in Cambodia (14), Ghana (1,2), and Bangladesh (8). This was true despite differences between studies in initial anemia rates, micronutrient composition and iron dosage of the Sprinkles, duration of treatment, study setting, and level of control over compliance with the intervention.
Differential impact in specific groups. Our results suggest that older children within the 6–24-mo-old range (i.e. children >21 mo at onset) who also consumed WSB did not benefit from Sprinkles to the same extent as younger children did. To the best of our knowledge, there is no evidence of such an interaction in previously reported analyses of the impact of Sprinkles. The absence of an impact of the Sprinkles intervention among older children could be due to factors such as lower iron requirements compared with younger children, greater gastric capacity, and longer duration of consumption of WSB. Our previous research in Haiti suggested that fortification levels of WSB were more likely to be adequate for older children than young infants (6); the Sprinkles study results support these findings.
The Sprinkles intervention was more effective for children who were anemic at baseline, regardless of age. Initial Hb levels are known to predict benefit from iron supplementation (15); thus, it is not surprising that 2 Sprinkles studies conducted on nonanemic children showed no impact on mean Hb concentrations (16,17). One Sprinkles efficacy trial in Bangladesh documented greater reductions in anemia among children who were anemic at baseline (8) but did not examine the range of impact with different levels of initial Hb.
Long-term impact of Sprinkles.
The only study on the long-term impact of Sprinkles showed that children who had recovered from anemia following a 2-mo treatment with 80 mg iron did not need further intervention to remain anemia-free for up to 1 y. Our study provides evidence that with much lower doses of iron (12.5 mg) over a 2-mo period, most children (92%) maintained their nonanemic status for at least 7 mo postintervention. A majority of children (76%) who were still anemic at 1st follow-up had recovered from anemia at 7 mo postintervention. Although the study no longer had a control group at the time of the 2nd follow-up, it is unlikely that other factors are responsible for the sustained impact of the Sprinkles over time. On the contrary, at the 1st follow-up, 13% of children had stopped receiving fortified WSB and at the 2nd follow-up, more than one-half of the children (55%) had not received the fortified food, because they were older than the phase-out age of 24 mo. Thus, access to iron-fortified foods declined during this period and none of the mothers reported purchasing or receiving Sprinkles once the intervention concluded. In fact, the 2000 Haiti Demographic and Health Survey showed that 39% of children 24–36 mo old in the Central Plateau region (where this study was conducted) were anemic (5). Therefore, it is highly plausible that the sustained improvements in mean Hb and reduction in anemia prevalence during the 7 mo following the Sprinkles intervention were attributable to the intervention.
The sustained impact of the Sprinkles beyond the period of intervention could be because children had not consumed the entire 60-sachet dose at the time of the 1st follow-up, or because the hematological response was still incomplete by then. Both possibilities are supported by a recent study where flexible dosing encouraging the use of 60 sachets over 2–4 mo was more effective in anemia reduction than recommending daily use for 2 mo (18).
Compliance. As with most previous studies using Sprinkles (8,14,16,18,19), compliance was high in our study. High compliance might have been facilitated by the relatively short duration of intervention, by close attention to the design of the BCC component of the intervention, and by the population's high level of trust in WV.
Morbidity. We found no differences between groups in morbidity symptoms throughout the study that could be attributable to the Sprinkles either in anemic or nonanemic groups, except for a slight elevation in diarrhea prevalence among nonanemic children at the beginning of the Sprinkles intervention but not thereafter. This pattern was also seen in 2 other studies (14,16) and does not raise serious concerns about the morbidity impact of a 2-mo regimen of Sprinkles in this setting.
The potential risk of giving additional iron to infants and young children is particularly important in malaria-endemic areas (20,21). Although Haiti is currently classified as a malaria-risk region by the CDC, recent studies suggest that malaria prevalence in Haiti is on the decline (22,23). However, considering that malaria still prevails in Haiti (24), close monitoring of morbidity and mortality outcomes is recommended for children consuming additional iron from sources such as Sprinkles for periods longer than 2 mo.
Strengths and weaknesses of the study. Previously published studies of the impact of Sprinkles have mostly been conducted in the context of efficacy trials, where the delivery of the intervention to the beneficiary is tightly controlled (1,2,8,14,17,19,25). Our study was conducted in a programmatic setting where neither intervention delivery nor intervention use was controlled by the researchers and thus allows the development of programmatic recommendations that are not possible from efficacy trials.
Our study had some limitations worth noting. First, the assessment of Hb was our main biological outcome, because the costs and logistical constraints of assessing other biological indicators of iron status were prohibitive in Haiti at the time of the study. Second, the study was conducted by measurers with knowledge of the treatment groups. Systematic measurement bias seems unlikely, however, because the results show the expected differences in impact across different levels of Hb and across ages, which were not known to the measurers. Third, differential regression to the mean could have influenced the changes in anemia prevalence and mean Hb observed in our study. We addressed this threat by adjusting for baseline Hb and anemia prevalence in our multivariate analyses.
Programmatic implications. There are 3 major programmatic implications of our research. First, in poor settings like rural Haiti, the distribution of iron-fortified cereal blends like WSB combined with other preventive nutrition and health services and a strong BCC strategy (26) fails to prevent anemia in young children. Thus, programs should not rely only on food commodities fortified at the level of WSB to control anemia in 6–24-mo-old children.
Second, our findings support the use of Sprinkles for reducing anemia among children between 9 and 24 mo of age in MCHN programs, regardless of whether they provide food assistance. Despite the smaller impact in children over 21 mo of age, programmatic targeting of all children 9- to 24-mo old is supported because: 1) accurate assessment of child age is often difficult in programmatic settings; 2) anemic children across the entire age range benefited; and 3) there were no adverse effects among nonanemic children.
Our results also provide evidence of effectiveness of Sprinkles even for children 6–8 mo at baseline, because no other iron interventions were delivered in the interim period between baseline and the start of the Sprinkles intervention when these children were 9 mo and older. However, research is needed on the safety of iron-containing products, including Sprinkles, among younger infants.
Third, our results support the recommendation that a 2-mo dose of Sprinkles (in the formulation tested in this study) is adequate for at least a 9-mo period following the onset of the intervention in this population receiving WSB until 24 mo of age. A 2-mo dose appears not only to help anemic children recover from anemia in the short term but also to protect them from becoming anemic or relapsing over the longer term (7 mo postintervention in our study). Because the only previous findings on long-term benefits used much higher doses of iron (17), we recommend research to compare different dosages, duration, and frequency of Sprinkles intake and identify the optimal programmatic options for populations with varying degrees of iron-deficiency anemia and other micronutrient deficiencies and health problems.
We conclude that in situations where diets are known to be low in iron and other important micronutrients, where malaria prevalence is not excessively high, and where screening for anemia is logistically and financially difficult, blanket use of Sprinkles for 2 mo along with fortified food aid commodities is clearly indicated for infants 9 and 24 mo of age and may also be recommended for infants 6–8 mo of age.
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ACKNOWLEDGMENTS |
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oise Vermeylen, and Rebecca Stoltzfus (Cornell University). We thank Chad Macarthur (Helen Keller International) and Altrena Mukuria (ORC Macro) for providing training materials in French. |
FOOTNOTES |
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6 Abbreviations used: BCC, behavior change and communication; FDP, food distribution point; Hb, hemoglobin; MCHN, maternal and child health and nutrition; S-WSB, Sprinkles+wheat-soy blend; WSB, wheat-soy blend; WV, World Vision.
7 Fortification levels of WSB for key nutrients (expressed on a per-100-g basis): 17.85 mg iron, 5.5 mg zinc, 2323 IU vitamin A as retinyl palmitate, 40 mg vitamin C, 275 µg folic acid.
8 Age at baseline, rather than age at the start of intervention, is used in all analyses, because it was measured by the research team and therefore was more accurate than age at start of intervention.
Manuscript received 4 August 2006. Initial review completed 28 September 2006. Revision accepted 23 January 2007.
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LITERATURE CITED |
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18 mo) children at baseline (P < 0.05 for age group at baseline x treatment interaction). Age at baseline was roughly 3 mo younger than age at onset of intervention due to delays in start of intervention. Values are adjusted means ± SE, n = 244 in S-WSB, and n = 154 in WSB. *Different from S-WSB, P < 0.05.
