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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00944853
Other study ID # 200917272
Secondary ID ZincTab
Status Completed
Phase N/A
First received July 21, 2009
Last updated February 22, 2017
Start date August 2009
Est. completion date February 2010

Study information

Verified date February 2010
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.


Description:

1) 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.


Recruitment information / eligibility

Status Completed
Enrollment 462
Est. completion date February 2010
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 23 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Liquid zinc syrup
Liquid zinc syrup containing 5 mg zinc as zinc sulfate
Zinc tablet
Dispersible zinc tablet containing 5 mg zinc
Liquid placebo supplement
Liquid placebo supplement containing 0 mg zinc

Locations

Country Name City State
Burkina Faso Toussiana Health District Toussiana

Sponsors (4)

Lead Sponsor Collaborator
University of California, Davis Helen Keller International, Nutriset S.A.S., Université Polytechnique de Bobo-Dioulasso

Country where clinical trial is conducted

Burkina Faso, 

References & Publications (1)

Wessells KR, Ouédraogo ZP, Rouamba N, Hess SY, Ouédraogo JB, Brown KH. Short-term zinc supplementation with dispersible tablets or zinc sulfate solution yields similar positive effects on plasma zinc concentration of young children in Burkina Faso: a rand — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma zinc concentration 3 weeks
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