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

February 18, 2010 updated by: University of California, Davis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Producer: UCD pharmacy
PLACEBO_COMPARATOR: Placebo supplement
Daily intake of placebo supplement
Dietary supplement: Placebo
Daily placebo for 3 weeks
Other Names:
  • Producer: UCD pharmacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma zinc concentration
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

USDA, Western Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 11, 2007

First Posted (ESTIMATE)

April 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2010

Last Update Submitted That Met QC Criteria

February 18, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200714985
  • SerumZinc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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