Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459485
Status:
COMPLETED
Last Update Posted:
2010-02-19
First Post:
2007-04-11
Brief Title:
Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on Plasma Zinc Concentration
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on the Magnitude and Velocity of Change in Plasma Zinc Concentration
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 zincd 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 mgd elemental zinc and the higher dose zinc supplement will contain 20 mgd 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SerumZinc | None | None | None |