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

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ClinicalTrials.gov Identifier: NCT00484627
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : June 11, 2007
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Procedure: Use of creatine monohydrate (a dietary supplement) Behavioral: Progressive resistance exercise training Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Supportive Care
Official Title: Ergogenic Effects of Creatine Supplementation in HIV Infection
Study Start Date : August 2001
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Muscle strength [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Muscle size [ Time Frame: 14 weeks ]
  2. Muscle energetics [ Time Frame: 14 weeks ]
  3. Body composition [ Time Frame: 14 weeks ]
  4. Biochemistries [ Time Frame: 14 weeks ]
  5. Safety [ Time Frame: Throughout the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484627


Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00484627     History of Changes
Other Study ID Numbers: R01AT000491-01 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: June 11, 2007
Last Verified: June 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Exercise
HIV
Creatine
Muscle

Additional relevant MeSH terms:
Infection
Communicable Diseases
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