Double-Blind, Placebo-Controlled Trial Comparing Effects of Supplementation with Two Different Combinations of Micronutrients Delivered as Sprinkles on Growth, Anemia, and Iron Deficiency in Cambodian Infants
What this study found
Both active sprinkle regimens improved anemia-related outcomes versus placebo, but neither showed a clear growth advantage. Hemoglobin increased over 12 months in the MMN group by 8.2 g/L and in the FFA group by 8.3 g/L, while it decreased in the placebo group by 3.20 g/L; end-of-study hemoglobin was higher with both active regimens than placebo (P < 0.0001). Recovery from anemia was 53.8% with MMN and 52.9% with FFA versus 21.7% with placebo (P < 0.001). Ferritin rose slightly in the active groups but declined in placebo, and iron deficiency increased in placebo from 31% at baseline to 52%…
- Study & population
- Double-blind, placebo-controlled randomized trial in Cambodian infants living in Tuk Phos district, Kompong Chhnang Province, Cambodia.
- Intervention
- Daily sprinkle sachets were mixed into the infant's cooked complementary meal at home for 12 months, starting 7 +/- 2 days after the baseline blood assessment.
- Key limitation
- Growth outcomes were not improved despite the micronutrient intervention, so the clinical benefit was limited to anemia and iron status.
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Open PDFOriginal abstract
Objectives: To assess and compare efficacy of two micronutrient sprinkle supplementation on growth, anemia, and iron deficiency in Cambodian infants. Methods: A total of 204 infants aged 6 months and living in Kompong Chhnang Province, Cambodia were randomly assigned to receive daily supplements of either iron (12.5 mg) plus folic acid (150 &mgr;g) plus zinc (5 mg) (MMN, n = 68), or iron (12.5 mg) plus folic acid (150 &mgr;g) alone (FFA, n = 68), or placebo (n = 68) for a 12 month period in powder form as sprinkles. Anthropometrics was evaluated bimonthly. Biochemical assessment was performed at baseline and at the end of intervention period. Results: At baseline, the overall mean (SD) of hemoglobin concentration was 101 g/L. No difference among groups was found for growth pattern. Significant decline was observed for weight-for-age and height-for-age z-scores in any group (P < 0.0001). The rate of recovery from anemia was significant (P < 0.001) and comparable between MMN (54%) and FFA (53%) groups and higher than in the placebo group (22%, P < 0.0001). Through the study period, no significant change in the rate of iron deficiency was found in MMN and FFA groups, whereas it increased in the placebo group (31%, baseline vs. 52%, end of study; P < 0.0001). Conclusion: Both MMN and FFA supplements were effective for preventing or treating anemia in Cambodian infants and stabilizing plasma levels of ferritin. Use of micronutrients in a controlled home setting, as sprinkled daily supplements, may be promising in preventing and treating anemia in developing countries.