Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes

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.

Conditions

• Anemia
• Diarrhea
• Iron

Interventions

DIETARY_SUPPLEMENT

iron and zinc combined

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.

DIETARY_SUPPLEMENT

iron and zinc on separate days

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.

DIETARY_SUPPLEMENT

iron

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.

DIETARY_SUPPLEMENT

Zinc

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.

DIETARY_SUPPLEMENT

placebo

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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• United States Agency for International Development (USAID)

  collaborator FED

• Agency for Healthcare Research and Quality (AHRQ)

  collaborator FED

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Robert E Black, MD, MPH · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

18 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-05-31

Primary Completion

2008-02-29

Completion

2008-02-29

Countries

• Bangladesh

Study Locations