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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Ergogenic Effects of Creatine Supplementation in HIV Infection

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00484627     History of Changes
Other Study ID Numbers: R01 AT000491-01
Study First Received: June 8, 2007
Last Updated: June 8, 2007
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Exercise
HIV
Creatine
Muscle

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 24, 2014