Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes
2 other identifiers
interventional
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 3, 2007
CompletedFirst Posted
Study publicly available on registry
May 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
September 19, 2011
CompletedApril 20, 2018
December 1, 2009
9 months
May 3, 2007
August 10, 2011
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Diarrhea
A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.
6 months
Secondary Outcomes (3)
Change in Hemoglobin
6 months
Change in Zinc Status
6 months
Percent Anemic
6 months
Study Arms (5)
combined iron and zinc
EXPERIMENTALIron and zinc together
Separate iron and zinc
EXPERIMENTALIron and zinc on separate days
iron alone
EXPERIMENTALIron
zinc alone
EXPERIMENTALZinc
placebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Children 6-18 months old
- Permanent residents of the selected villages
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICDDR,B
Dhaka, Mohakhali, 1212, Bangladesh
Related Publications (1)
Chang S, El Arifeen S, Bari S, Wahed MA, Rahman KM, Rahman MT, Mahmud AB, Begum N, Zaman K, Baqui AH, Black RE. Supplementing iron and zinc: double blind, randomized evaluation of separate or combined delivery. Eur J Clin Nutr. 2010 Feb;64(2):153-60. doi: 10.1038/ejcn.2009.127. Epub 2009 Nov 11.
PMID: 19904293RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephanie Chang
- Organization
- AHRQ
Study Officials
- PRINCIPAL INVESTIGATOR
Robert E Black, MD, MPH
Johns Hopkins Bloomberg School of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2007
First Posted
May 7, 2007
Study Start
May 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 20, 2018
Results First Posted
September 19, 2011
Record last verified: 2009-12