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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00459485
Enrollment
58
Registered
2007-04-12
Start date
2007-04-30
Completion date
2007-12-31
Last updated
2010-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zinc Deficiency

Keywords

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

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.

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.

Interventions

DIETARY_SUPPLEMENTzinc sulfate

20 or 10 mg zinc per day for 3 weeks

DIETARY_SUPPLEMENTPlacebo

Daily placebo for 3 weeks

Sponsors

USDA, Western Human Nutrition Research Center
CollaboratorFED
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
19 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Plasma zinc concentration3 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026