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

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

Sponsors

Lead Sponsor: University of California, Davis

Collaborator: Université Polytechnique de Bobo-Dioulasso
Helen Keller International
Nutriset

Source University of California, Davis
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

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.

Overall Status Completed
Start Date August 2009
Completion Date February 2010
Primary Completion Date December 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Plasma zinc concentration 3 weeks
Enrollment 462
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Liquid zinc syrup

Description: Liquid zinc syrup containing 5 mg zinc as zinc sulfate

Arm Group Label: Zinc syrup

Other Name: Phytofla, Banfora, Burkina Faso

Intervention Type: Dietary Supplement

Intervention Name: Zinc tablet

Description: Dispersible zinc tablet containing 5 mg zinc

Arm Group Label: Zinc tablet

Other Name: Nutriset S.A.S., France

Intervention Type: Dietary Supplement

Intervention Name: Liquid placebo supplement

Description: Liquid placebo supplement containing 0 mg zinc

Arm Group Label: Placebo

Other Name: Phytofla, Banfora, Burkina Faso

Eligibility

Criteria:

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

Gender: All

Minimum Age: 6 Months

Maximum Age: 23 Months

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kenneth H Brown, MD Principal Investigator University of California, Davis
Location
Facility: Toussiana Health District
Location Countries

Burkina Faso

Verification Date

February 2010

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Zinc syrup

Type: Experimental

Description: Liquid Zinc Syrup (ZnSO4) solution provided daily

Label: Zinc tablet

Type: Experimental

Description: Dispersible zinc tablets provided daily

Label: Placebo

Type: Placebo Comparator

Description: Liquid placebo supplement provided daily

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov