Knee OsteoarthritisNCT00749983
Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia
A study testing Creatine supplementation and Dextrose supplementation in people with Knee Osteoarthritis and Fibromyalgia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia. Read more about this study
- Who is it for?
- Ages 25 to 80 years, women only
- Conditions the study is for
- Knee Osteoarthritis, Fibromyalgia
- What is being tested?
- Creatine supplementation and Dextrose supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Jul 2012
- Phase
- Interventional
- 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 25 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfill ACR criteria of knee osteoarthritis
- Fulfill ACR criteria of fibromyalgia
Who cannot join
- Athletes
- Drugs stable for at least three months before entering the study
- No limitations to resistance training
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo School of Medicine
São Paulo, São Paulo, 01246903
About this study
The purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.
- Conditions
- Knee Osteoarthritis, Fibromyalgia
- Being tested
- Creatine supplementation, Dextrose supplementation
- Medical subject headings
- Osteoarthritis, Knee, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine supplementationDietary supplement
Dextrose supplementationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | creatine intake Receives: Dietary Supplement: Creatine supplementation |
| 2 | Placebo comparator | placebo (dextrose) intake Receives: Dietary Supplement: Dextrose supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Assessed by the timed-stands test
Measured: 12 weeks
Secondary outcomes (4)
Strength
Assessed by the 1-repetition maximum test
Measured: 12 weeks
Quality of life
health-related questionaires
Measured: 12 weeks
Body composition
Assessed by DXA
Measured: 12 weeks
Renal function
Assessed by 51Cr-EDTA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startJun 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749983
- Sponsor's protocol ID
- 0849/07
- Status last verified
- Oct 2012
- First submitted
- 9 Sep 2008
- Last updated
- 2 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia
- ClinicalTrials.gov ID
- NCT00749983
- Acronym / sponsor ID
- 0849/07
- Conditions
- Knee Osteoarthritis, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Sep 2008 (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.
The purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Creatine supplementationcreatine intake |
| 2 | Placebo comparator | Dietary Supplement: Dextrose supplementationplacebo (dextrose) intake |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fulfill ACR criteria of knee osteoarthritis
- Fulfill ACR criteria of fibromyalgia
Key exclusion criteria (3 listed)
- Athletes
- Drugs stable for at least three months before entering the study
- No limitations to resistance training
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 |
|---|---|---|
| Creatine supplementation | Dietary supplement | 1 |
| Dextrose supplementation | Dietary supplement | 2 |
Primary outcome
Physical function
Time frame: 12 weeks
Assessed by the timed-stands test
4 secondary outcomes
Strength
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Renal function
Time frame: 12 weeks
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 2 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine supplementation and Dextrose supplementation in people with Knee Osteoarthritis and Fibromyalgia, run by University of Sao Paulo at 1 site in Brazil.
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 3 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 2 Oct 2012. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Physical function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2012.