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

June 8, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle strength
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscle size
Time Frame: 14 weeks
14 weeks
Muscle energetics
Time Frame: 14 weeks
14 weeks
Body composition
Time Frame: 14 weeks
14 weeks
Biochemistries
Time Frame: 14 weeks
14 weeks
Safety
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

June 8, 2007

First Submitted That Met QC Criteria

June 8, 2007

First Posted (Estimate)

June 11, 2007

Study Record Updates

Last Update Posted (Estimate)

June 11, 2007

Last Update Submitted That Met QC Criteria

June 8, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT000491-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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