Viewing Study NCT00484627



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Study NCT ID: NCT00484627
Status: COMPLETED
Last Update Posted: 2007-06-11
First Post: 2007-06-08

Brief Title: Effects of Creatine and Resistance Exercise Training in People With HIV Infection
Sponsor: National Center for Complementary and Integrative Health NCCIH
Organization: National Center for Complementary and Integrative Health NCCIH

Study Overview

Official Title: Ergogenic Effects of Creatine Supplementation in HIV Infection
Status: COMPLETED
Status Verified Date: 2007-06
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 study was designed determine whether use of creatine monohydrate a dietary supplement can increase skeletal muscle mass and strength and improve the response to progressive resistance exercise training in people with HIV infection
Detailed Description: This is a randomized placebo-controlled study to evaluate the effect of creatine monohydrate a dietary supplement on skeletal muscle size and function ie strength energy metabolism work capacity fatigue whole-body exercise performance and body composition This study is also designed to determine whether creatine supplementation augments the functional benefit derived from progressive resistance exercise The safety of creatine supplementation in people with HIV infection will also be evaluated Forty HIV-positive subjects will be randomly assigned on a 11 basis to receive creatine monohydrate or placebo for a period of 14 days followed by a 12-week program of supervised progressive resistance exercise training during which administration of creatine monohydrate or placebo will continue

Measurements of muscle strength size composition energetics and fatigue as well as body weight and composition and serum biochemistries will be made at baseline after two weeks of treatment with creatine or placebo before PRT and again after 12 weeks of PRT study week 14 Safety will be monitored throughout the study

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