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

February 22, 2017 updated by: University of California, Davis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

462

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Toussiana, Burkina Faso
        • Toussiana Health District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinc syrup
Liquid Zinc Syrup (ZnSO4) solution provided daily
Dietary supplement: Liquid zinc syrup
Liquid zinc syrup containing 5 mg zinc as zinc sulfate
Other Names:
  • Phytofla, Banfora, Burkina Faso
Experimental: Zinc tablet
Dispersible zinc tablets provided daily
Dietary supplement: Zinc tablet
Dispersible zinc tablet containing 5 mg zinc
Other Names:
  • Nutriset S.A.S., France
Placebo Comparator: Placebo
Liquid placebo supplement provided daily
Dietary supplement: Liquid placebo supplement
Liquid placebo supplement containing 0 mg zinc
Other Names:
  • Phytofla, Banfora, Burkina Faso

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma zinc concentration
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Helen Keller International
Université Polytechnique de Bobo-Dioulasso
Nutriset

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200917272
  • ZincTab

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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