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
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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. |
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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. |
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Overall Status | Completed | ||||||
Start Date | August 2009 | ||||||
Completion Date | February 2010 | ||||||
Primary Completion Date | December 2009 | ||||||
Phase | N/A | ||||||
Study Type | Interventional | ||||||
Primary Outcome |
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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 |
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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 |
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Overall Official |
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Location |
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Location Countries |
Burkina Faso |
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Verification Date |
February 2010 |
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Responsible Party |
Type: Sponsor |
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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 |
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Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |