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

This study has been completed.
Sponsor:
Collaborator:
USDA, Western Human Nutrition Research Center
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00459485
First received: April 11, 2007
Last updated: February 18, 2010
Last verified: February 2010
  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 Phase
Zinc Deficiency
Dietary Supplement: zinc sulfate
Dietary Supplement: Placebo
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: Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on the Magnitude and Velocity of Change in Plasma Zinc Concentration

Resource links provided by NLM:


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: 58
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc supplement (20 mg)
Daily intake of 20 mg supplementary zinc
Dietary Supplement: zinc sulfate
20 or 10 mg zinc per day for 3 weeks
Other Name: Producer: UCD pharmacy
Experimental: Zinc supplement (10 mg)
Daily intake of 10 mg supplementary zinc
Dietary Supplement: zinc sulfate
20 or 10 mg zinc per day for 3 weeks
Other Name: Producer: UCD pharmacy
Placebo Comparator: Placebo supplement
Daily intake of placebo supplement
Dietary Supplement: Placebo
Daily placebo for 3 weeks
Other Name: Producer: UCD pharmacy

Detailed Description:

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
University of California, Davis
USDA, Western Human Nutrition Research Center
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: Kenneth Brown, University of California
ClinicalTrials.gov Identifier: NCT00459485     History of Changes
Other Study ID Numbers: 200714985, SerumZinc
Study First Received: April 11, 2007
Last Updated: February 18, 2010
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

Additional relevant MeSH terms:
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014