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Clinical Trial 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.


Clinical Trial Description

This is a randomized, placebo-controlled study to evaluate the effect of creatine monohydrate, a dietary supplement, on skeletal muscle size and function (i.e., 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 1:1 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00484627
Study type Interventional
Source National Center for Complementary and Integrative Health (NCCIH)
Contact
Status Completed
Phase Phase 2
Start date August 2001
Completion date October 2003

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