A Phase 4 interventional study of zinc sulfate and Placebo in Zinc Deficiency, sponsored by University of California, Davis. Completed. Open to male participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-19.
Sponsored by University of California, Davis · Phase 4, Interventional, and Prevention
This is a double-blind, randomized controlled trial conducted in men 19-65 years of age who will receive daily zinc supplements (10 or 20 mg zinc/d as zinc sulfate) or placebo for 21 days. Blood samples for plasma zinc and CRP concentrations will be drawn at baseline and days 1, 2, 5, 9, 14, and 21 during supplementation and days 1, 2, 5, 9, and 14 after discontinuation of supplementation.
The study will be a double blind, randomized, placebo controlled trial conducted in men 19-65 years of age. Participants will receive daily zinc or placebo liquid supplements for 21 days. Supplemental zinc will be given as zinc sulfate; the lower dose zinc supplement will contain 10 mg/d elemental zinc, and the higher dose zinc supplement will contain 20 mg/d elemental zinc. The placebo will contain the same excipients expect for zinc sulfate.
Multiple blood draws will be performed throughout the course of the study, to determine the responsiveness of plasma zinc concentrations to zinc supplementation. Two baseline blood draws will occur prior to the start of supplementation (study days -7 and 0). Blood draws will be performed on days 1, 2, 5, 9, 14 and 21 of the 21 day supplementation period. Upon termination of supplementation (day 21), blood draws will be performed on days 1, 2, 5, 9, 14 and 21 post-supplementation (study days 22, 23, 26, 30, 35 and 42).
The major outcomes of interest are the magnitude and velocity of change in plasma zinc concentration. Other outcomes to be assessed are plasma concentrations of the acute phase proteins CRP and AGP, as well as reported morbidity, because of their potential roles as confounding variables. Anthropometric variables will be assessed at baseline.
University of California, Davis is the lead sponsor of 809 studies on the registry; 145 are open to participants now.
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Exclusion Criteria:
Daily intake of 20 mg supplementary zinc
Dietary Supplement: zinc sulfate
Daily intake of 10 mg supplementary zinc
Dietary Supplement: zinc sulfate
Daily intake of placebo supplement
Dietary Supplement: Placebo
20 or 10 mg zinc per day for 3 weeks
Also known as: Producer: UCD pharmacy
Daily placebo for 3 weeks
Also known as: Producer: UCD pharmacy
Plasma zinc concentration
Time frame: 3 weeks
No study locations are listed for this record.
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zinc Sulfate
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