Phase 4
Completed N=1,000
Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes
Source: ClinicalTrials.gov NCT00470158 ↗Enrolled (actual)
1,000
Serious AEs
6.8%
Results posted
Sep 2011
Primary outcomePrimary: Incidence of Diarrhea — 201; 204; 260; 224 episodes
Summary
With the long-term public health goal of developing an effective micronutrient supplementation program to improve child health by improving iron and zinc status and decreasing morbidity due to diarrhea in areas with high rates of childhood malnutrition, we seek to determine the most efficacious method of decreasing childhood morbidity and mortality due to diarrhea in toddlers by re-examining the issue of iron and zinc interaction and determining if this interaction can be minimized by separate administration of iron and zinc supplementation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Diarrhea |
201; 204; 260; 224; 235 | — |
| SECONDARY Change in Hemoglobin |
— | — |
| SECONDARY Change in Zinc Status |
— | — |
| SECONDARY Percent Anemic |
— | — |
Eligibility Criteria
Inclusion Criteria
- Children 6-18 months old
- Permanent residents of the selected villages
Exclusion Criteria
- Severe malnutrition requiring hospitalization (defined as weight for height <-3 SD Z-score)
- Severe anemia requiring treatment (hemoglobin < 70 g/L)
- Chronic illness that would impair feeding ability
- Likely to move in next 6 months.
- Fever greater than 38.5
- Regular iron supplementation
Data sourced from ClinicalTrials.gov (NCT00470158). 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.