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

Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459485
• Other study ID #: 200714985
• Secondary ID: SerumZinc
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2007
• Last updated: February 18, 2010
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2010
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

Dietary Supplement:
• zinc sulfate
20 or 10 mg zinc per day for 3 weeks
• Placebo
Daily placebo for 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	USDA, Western Human Nutrition Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma zinc concentration		3 weeks	No