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

This study is not yet open for participant recruitment.

Verified by University of California, Davis, April 2007

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00459485

Purpose

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.

Condition	Intervention
Healthy	Drug: zinc sulfate

Drug Information available for: Zinc sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on the Magnitude and Velocity of Change in Plasma Zinc Concentration

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

Primary Outcome Measures:

Plasma zinc concentration

Estimated Enrollment:	75
Study Start Date:	April 2007
Estimated Study Completion Date:	January 2008

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459485

Contacts

Contact: Sonja Y Hess, PhD

530-752-1992

syhess@ucdavis.edu

Locations

United States, California
Department of Nutrition, University of California, Davis
Davis, California, United States, 95616

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Kenneth H Brown, MD

University of California, Davis

More Information

Study ID Numbers:	SerumZinc
Study First Received:	April 11, 2007
Last Updated:	April 11, 2007
ClinicalTrials.gov Identifier:	NCT00459485
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Plasm zinc concentration
Zinc supplementation
Assessment of zinc status
Plasma zinc concentration

Study placed in the following topic categories:

Zinc Sulfate
Zinc
Healthy

Additional relevant MeSH terms:

Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Astringents

Trace Elements
Micronutrients
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009