NCT00459485

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 19, 2010

Status Verified

February 1, 2010

Enrollment Period

8 months

First QC Date

April 11, 2007

Last Update Submit

February 18, 2010

Conditions

Zinc Deficiency

Keywords

Plasm zinc concentrationZinc supplementationAssessment of zinc statusPlasma zinc concentration

Outcome Measures

Primary Outcomes (1)

  • Plasma zinc concentration

    3 weeks

Study Arms (3)

Zinc supplement (20 mg)

EXPERIMENTAL

Daily intake of 20 mg supplementary zinc

Dietary Supplement: zinc sulfate

Zinc supplement (10 mg)

EXPERIMENTAL

Daily intake of 10 mg supplementary zinc

Dietary Supplement: zinc sulfate

Placebo supplement

PLACEBO COMPARATOR

Daily intake of placebo supplement

Dietary Supplement: Placebo

Interventions

zinc sulfateDIETARY_SUPPLEMENT

20 or 10 mg zinc per day for 3 weeks

Also known as: Producer: UCD pharmacy
Zinc supplement (10 mg)Zinc supplement (20 mg)
PlaceboDIETARY_SUPPLEMENT

Daily placebo for 3 weeks

Also known as: Producer: UCD pharmacy
Placebo supplement

Eligibility Criteria

Age19 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally health men
  • years
  • Non-anemic

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wessells KR, Jorgensen JM, Hess SY, Woodhouse LR, Peerson JM, Brown KH. Plasma zinc concentration responds rapidly to the initiation and discontinuation of short-term zinc supplementation in healthy men. J Nutr. 2010 Dec;140(12):2128-33. doi: 10.3945/jn.110.122812. Epub 2010 Oct 13.

    PMID: 20943956DERIVED

MeSH Terms

Interventions

Zinc Sulfate

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Kenneth H Brown, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 12, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 19, 2010

Record last verified: 2010-02