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

This study has been completed.
Sponsor:
Collaborators:
Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso
Helen Keller International
Nutriset S.A.S.
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00944853
First received: July 21, 2009
Last updated: February 18, 2010
Last verified: February 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Zinc Deficiency
 Dietary Supplement: Liquid zinc supplement
Dietary Supplement: Zinc tablet
Dietary Supplement: Liquid placebo supplement
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Plasma zinc concentration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 462
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc syrup
Liquid ZnSO4 solution provided daily
 Dietary Supplement: Liquid zinc supplement
Liquid zinc supplement 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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 23 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944853

Locations
Burkina Faso
Toussiana Health District
Toussiana, Burkina Faso
Sponsors and Collaborators
University of California, Davis
Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso
Helen Keller International
Nutriset S.A.S.
Investigators
Principal Investigator: Kenneth H Brown, MD University of California, Davis
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Kenneth H. Brown, University of California Davis
ClinicalTrials.gov Identifier: NCT00944853     History of Changes
Other Study ID Numbers: 200917272, ZincTab
Study First Received: July 21, 2009
Last Updated: February 18, 2010
Health Authority: Burkina Faso: Ministry of Health

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013