Effects of Creatine and Resistance Exercise Training in People With HIV Infection - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00484627

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Procedure: Use of creatine monohydrate (a dietary supplement) Behavioral: Progressive resistance exercise training	Phase II

MedlinePlus related topics: AIDS Dietary Supplements Exercise and Physical Fitness

Drug Information available for: Creatine Creatine monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Ergogenic Effects of Creatine Supplementation in HIV Infection

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Muscle strength [ Time Frame: 14 weeks ]

Secondary Outcome Measures:

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 ]

Enrollment:	43
Study Start Date:	August 2001
Study Completion Date:	October 2003

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 (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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484627

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

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

More Information

Study ID Numbers:	R01 AT000491-01
Study First Received:	June 8, 2007
Last Updated:	June 8, 2007
ClinicalTrials.gov Identifier:	NCT00484627
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Exercise
HIV
Creatine
Muscle

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009