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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00944853
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : February 24, 2017
Sponsor:
Collaborators:
Université Polytechnique de Bobo-Dioulasso
Helen Keller International
Nutriset S.A.S.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Zinc Deficiency Dietary Supplement: Liquid zinc syrup Dietary Supplement: Zinc tablet Dietary Supplement: Liquid placebo supplement

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  (Clinical Trial)
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 : August 2009
Primary Completion Date : December 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Phytofla, Banfora, Burkina Faso
Experimental: Zinc tablet
Dispersible zinc tablets provided daily
Dietary Supplement: Zinc tablet
Dispersible zinc tablet containing 5 mg zinc
Other Name: 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 Name: Phytofla, Banfora, Burkina Faso



Primary Outcome Measures :
  1. Plasma zinc concentration [ Time Frame: 3 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944853


Locations
Burkina Faso
Toussiana Health District
Toussiana, Burkina Faso
Sponsors and Collaborators
University of California, Davis
Université Polytechnique de Bobo-Dioulasso
Helen Keller International
Nutriset S.A.S.
Investigators
Principal Investigator: Kenneth H Brown, MD University of California, Davis

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00944853     History of Changes
Other Study ID Numbers: 200917272
ZincTab
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 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
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs