N/A
Completed N=223
Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India
Iron Deficiency · Zinc Deficiency
Source: ClinicalTrials.gov NCT02233764 ↗
Enrolled (actual)
223
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Hemoglobin (g/dL) — 10.90; 10.30 g/dL
Summary
In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure iron status, growth and immune function in comparison to children receiving non-biofortified pearl millet.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin (g/dL) |
0.10; -0.20 | — |
| PRIMARY Iron Status |
7.30; 4.70 | — |
| PRIMARY Iron Status BRINDA Adjusted |
-1.27; -1.99 | — |
| PRIMARY Physical Growth |
-0.2; -0.2 | — |
| PRIMARY Immune Function |
23.08; 0.74 | — |
Eligibility Criteria
Inclusion Criteria
- Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
- Hemoglobin ≥9 g/dL
Exclusion Criteria
- Age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit)
- Hemoglobin 1 day hospitalization
- Children who do not have a caretaker to bring him/her to feeding center
- Possibility of migrating out of the slum dwelling for longer than 4 weeks
- Prior or current consumption of iron or zinc supplements in the past 1 year
- Any known dietary allergies
Data sourced from ClinicalTrials.gov (NCT02233764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.