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

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT00944853
Collaborator
Université Polytechnique de Bobo-Dioulasso (Other), Helen Keller International (Other), Nutriset (Industry)
462
Enrollment
1
Location
3
Arms
6
Duration (Months)
76.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Liquid zinc syrup
  • Dietary Supplement: Zinc tablet
  • Dietary Supplement: Liquid placebo supplement
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
462 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma zinc concentration [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 23 Months
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Toussiana Health District Toussiana Burkina Faso

    Sponsors and Collaborators

    • University of California, Davis
    • Université Polytechnique de Bobo-Dioulasso
    • Helen Keller International
    • Nutriset

    Investigators

    • Principal Investigator: Kenneth H Brown, MD, University of California, Davis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT00944853
    Other Study ID Numbers:
    • 200917272
    • ZincTab
    First Posted:
    Jul 23, 2009
    Last Update Posted:
    Feb 24, 2017
    Last Verified:
    Feb 1, 2010
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, Davis
    zinc supplement
    prevention
    zinc deficiency
    plasma zinc concentration
    Additional relevant MeSH terms:
    Zinc

    Study Results

    No Results Posted as of Feb 24, 2017