NCT00944853CompletedNot Applicable
The Effect of Zinc Supplementation, Provided as Either a Liquid Zinc Solution or Dispersible Tablets, on Plasma Zinc Concentration Among Young Burkinabe Children
University of California, Davis1 site in 1 country462 target enrollmentStarted: August 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 462
- Locations
- 1
- Primary Endpoint
- Plasma zinc concentration
Study Overview
Brief Summary
The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.
Detailed Description
- To investigate the effects of short-term zinc supplementation, provided either as a dispersible tablet containing zinc sulfate ("ZinCfant," Nutriset Ltd; Malaunay, France) or as a liquid ZnSO4 solution, on changes in serum zinc concentration, compared with a placebo in young Burkinabe children; and 2) to assess the relationship between change in serum zinc concentration and the presence of altered intestinal permeability within each treatment group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 23 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •currently breast feeding
- •informed consent of a parent or guardian.
Exclusion Criteria
- •symptomatic acute or chronic febrile infections
- •diarrhea within the past week
- •consuming vitamin or mineral supplements or zinc-fortified infant formulas
Arms & Interventions
Zinc syrup
Experimental
Liquid Zinc Syrup (ZnSO4) solution provided daily
Intervention: Liquid zinc syrup (Dietary Supplement)
Zinc tablet
Experimental
Dispersible zinc tablets provided daily
Intervention: Zinc tablet (Dietary Supplement)
Placebo
Placebo Comparator
Liquid placebo supplement provided daily
Intervention: Liquid placebo supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Plasma zinc concentration
Time Frame: 3 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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