Effects of Liquid Zinc Supplementation and Dispersible Zinc Tablets on Plasma Zinc Concentration

Zinc Deficiency Clinical Trial

Official title:

The Effect of Zinc Supplementation, Provided as Either a Liquid Zinc Solution or Dispersible Tablets, on Plasma Zinc Concentration Among Young Burkinabe Children

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
• 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

Related Conditions & MeSH terms

• Zinc Deficiency

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