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Completed

NCT Number: NCT00459485

Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on Plasma Zinc Concentration

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.

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Key information

Conditions

Age range

19 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally health men
  • 19-65 years
  • Non-anemic

Exclusion criteria

  • Age <19 or >65
  • Hemoglobin <120 g/L
  • Clinical evidence of illness
  • Consumption of mineral supplements
  • Recent blood donation (within 8 weeks)

Treatment and study plan

zinc sulfate

Dietary Supplement

20 or 10 mg zinc per day for 3 weeks

Other names: Producer: UCD pharmacy

Placebo

Dietary Supplement

Daily placebo for 3 weeks

Other names: Producer: UCD pharmacy

Primary outcomes

  1. Plasma zinc concentration

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • USDA, Western Human Nutrition Research Center

Registry information

Official study title

Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on the Magnitude and Velocity of Change in Plasma Zinc Concentration

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 12, 2007
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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