Back to resultsEffects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia
Primary Purpose
Knee Osteoarthritis, Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Creatine supplementation
Dextrose supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Fulfill ACR criteria of knee osteoarthritis
- Fulfill ACR criteria of fibromyalgia
Exclusion Criteria:
- Athletes
- Drugs stable for at least three months before entering the study
- No limitations to resistance training
Sites / Locations
- University of Sao Paulo School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
creatine intake
placebo (dextrose) intake
Outcomes
Primary Outcome Measures
Physical function
Assessed by the timed-stands test
Secondary Outcome Measures
Strength
Assessed by the 1-repetition maximum test
Quality of life
health-related questionaires
Body composition
Assessed by DXA
Renal function
Assessed by 51Cr-EDTA
Full Information
NCT ID
NCT00749983
First Posted
September 9, 2008
Last Updated
October 1, 2012
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00749983
Brief Title
Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
creatine intake
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo (dextrose) intake
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Dextrose supplementation
Primary Outcome Measure Information:
Title
Physical function
Description
Assessed by the timed-stands test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Strength
Description
Assessed by the 1-repetition maximum test
Time Frame
12 weeks
Title
Quality of life
Description
health-related questionaires
Time Frame
12 weeks
Title
Body composition
Description
Assessed by DXA
Time Frame
12 weeks
Title
Renal function
Description
Assessed by 51Cr-EDTA
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fulfill ACR criteria of knee osteoarthritis
Fulfill ACR criteria of fibromyalgia
Exclusion Criteria:
Athletes
Drugs stable for at least three months before entering the study
No limitations to resistance training
Facility Information:
Facility Name
University of Sao Paulo School of Medicine
City
Sao Paulo
ZIP/Postal Code
01246903
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia
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