Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes
Condition: Anemia; Diarrhea; Iron
MeSH terms: Diarrhea
Intervention: iron and zinc combined; iron and zinc on separate days; iron; Zinc; placebo
Intervention description: Children >= 12 months received an average of 5mg zinc/day, 6.25 Iron/day, and 25IU folic acid/day. children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.; Children >= 12 months received an average of 5mg zinc/day, alternating daily with 6.25 Iron/day, and 25IU folic acid/day. Children<12 received half that dose. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.; Children >= 12 months received an average 6.25 Iron/day, and 25IU folic acid/day. Children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.; Children >= 12 months received an average of 5mg zinc/day. Children<12 received half that dose. This dose was alternated daily with placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.; Children received daily placebo. Dissolvable doses were distributed in blister packs and reconstituted with a teaspoon of water. Doses were administered in the morning. For missed doses, the mother gave the child the next morning dose, and a second dose in the evening.
Intervention MeSH terms: Iron; Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1000.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: zinc; iron; interaction; diarrhea; delivery

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.
    

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