HIV InfectionsPhase 2NCT00484627
Effects of Creatine and Resistance Exercise Training in People With HIV Infection
A Phase 2 study testing Use of creatine monohydrate (a dietary supplement) and Progressive resistance exercise training in people with HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Use of creatine monohydrate (a dietary supplement) and Progressive resistance exercise training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Oct 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Use of creatine monohydrate (a dietary supplement), Progressive resistance exercise training
- Keywords
- Exercise, HIV, Creatine, Muscle
- Medical subject headings
- HIV Infections, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of creatine monohydrate (a dietary supplement)Procedure or surgery
Progressive resistance exercise trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Measured: 14 weeks
Secondary outcomes (5)
Muscle size
Measured: 14 weeks
Muscle energetics
Measured: 14 weeks
Body composition
Measured: 14 weeks
Biochemistries
Measured: 14 weeks
Safety
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startAug 2001
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Morris Schambelan, MD, Principal investigator, University of California, San Francisco; San Francisco General HospitalKathleen Mulligan, PhD, Study director, University of California, San Francisco; San Francisco General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484627
- Sponsor's protocol ID
- R01AT000491-01
- Status last verified
- Jun 2007
- First submitted
- 8 Jun 2007
- Last updated
- 11 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1371/journal.pone.0004605. Epub 2009 Feb 26.
PubMed 19242554
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergogenic Effects of Creatine Supplementation in HIV Infection
- ClinicalTrials.gov ID
- NCT00484627
- Acronym / sponsor ID
- R01AT000491-01
- Conditions
- HIV Infections
- Keywords
- Exercise, HIV, Creatine, Muscle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 2001
- Study completion
- Oct 2003 (actual)
- First posted
- 11 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of creatine monohydrate (a dietary supplement) | Procedure or surgery | – |
| Progressive resistance exercise training | Behavioural | – |
Primary outcome
Muscle strength
Time frame: 14 weeks
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2007.
- Derived from this study: PubMed 19242554Sakkas 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. doi: 10.1371/journal.pone.0004605. Epub 2009 Feb 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morris Schambelan, MD principal investigator
University of California, San Francisco; San Francisco General Hospital
Kathleen Mulligan, PhD study director
University of California, San Francisco; San Francisco General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Use of creatine monohydrate (a dietary supplement) and Progressive resistance exercise training in people with HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2007.