Effects of Creatine and Resistance Exercise Training in People With HIV Infection

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00484627
First received: June 8, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 8, 2007
June 8, 2007
August 2001
Not Provided
Muscle strength [ Time Frame: 14 weeks ]
Same as current
No Changes Posted
  • Muscle size [ Time Frame: 14 weeks ]
  • Muscle energetics [ Time Frame: 14 weeks ]
  • Body composition [ Time Frame: 14 weeks ]
  • Biochemistries [ Time Frame: 14 weeks ]
  • Safety [ Time Frame: Throughout the study ]
Same as current
Not Provided
Not Provided
 
Effects of Creatine and Resistance Exercise Training in People With HIV Infection
Ergogenic Effects of Creatine Supplementation in HIV Infection

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
HIV Infections
  • Procedure: Use of creatine monohydrate (a dietary supplement)
  • Behavioral: Progressive resistance exercise training
Not Provided
Sakkas GK, Mulligan K, Dasilva M, Doyle JW, Khatami H, Schleich T, Kent-Braun JA, Schambelan M. Creatine fails to augment the benefits from resistance training in patients with HIV infection: a randomized, double-blind, placebo-controlled study. PLoS ONE. 2009;4(2):e4605. Epub 2009 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
October 2003
Not Provided

Inclusion Criteria:

  • Clinically stable, sedentary HIV-positive adults who are on optimized antiretroviral regimens and plan to remain so during the study.
  • Men and women on hormone replacement therapy and women using hormonal contraceptives must have been on stable regimens for the preceding 6 months and plan to continue on such treatment throughout the study period.

Exclusion Criteria:

  • Serum creatinine > 1.5 mg/dl or clinical evidence of renal disease or prior kidney transplant
  • Creatine kinase (CK) > 1.5 times the upper limit of normal (ULN)
  • Hemoglobin < 8.5 g/dl
  • AST, ALT, or LDH > 5 X ULN
  • Uncontrolled diarrhea (> 6 stools per day)
  • Impaired oral intake
  • Persistent nausea or vomiting
  • Untreated hypogonadism
  • Pharmacologic use of growth hormone, testosterone, oxandrolone, nandrolone decanoate, oxymetholone, or other oral, injectable, or transdermal anabolic steroids, androstenedione, or dehydroepiandrosterone (DHEA) within the preceding 6 months (subjects with documented hypogonadism on stable testosterone replacement, defined as a dose < 300 mg q2 weeks for the preceding 6 months, will be allowed to enroll)
  • Use of glucocorticoids, megestrol acetate, creatine monohydrate, cytokine inhibitors (thalidomide, pentoxifylline, ketotifen), drugs known to adversely affect renal function, cytokines, parenteral or tube feeding, or initiation of treatment for a systemic infection within 30 days prior to enrollment
  • History of angina, coronary heart disease, or congestive heart failure
  • Current pregnancy or lactation or plans to become pregnant.
  • Because vegetarians are known to have lower intramuscular concentrations of creatine and therefore may experience a much greater relative increase in muscle creatine levels, we will exclude such individuals from this study.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00484627
R01 AT000491-01
No
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Morris Schambelan, MD University of California, San Francisco; San Francisco General Hospital
Study Director: Kathleen Mulligan, PhD University of California, San Francisco; San Francisco General Hospital
National Center for Complementary and Alternative Medicine (NCCAM)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP