Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bruno Gualano, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT00749983

First received: September 9, 2008

Last updated: October 1, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 9, 2008
Last Updated Date	October 1, 2012
Start Date ^ICMJE	June 2009
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 18, 2010)	Physical function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Assessed by the timed-stands test
Original Primary Outcome Measures ^ICMJE (submitted: September 9, 2008)	Timed-stands test and timed up-and-go [ Time Frame: Before and after 12 weeks of exercise training ]
Change History	Complete list of historical versions of study NCT00749983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 1, 2012)	Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Assessed by the 1-repetition maximum test Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] health-related questionaires Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Assessed by DXA Renal function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] Assessed by 51Cr-EDTA
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Knee Osteoarthritis Fibromyalgia
Intervention ^ICMJE	Dietary Supplement: Creatine supplementation Dietary Supplement: Dextrose supplementation
Study Arm (s)	Experimental: 1 creatine intake Intervention: Dietary Supplement: Creatine supplementation Placebo Comparator: 2 placebo (dextrose) intake Intervention: Dietary Supplement: Dextrose supplementation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	July 2012
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	25 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT00749983
Other Study ID Numbers ^ICMJE	0849/07
Has Data Monitoring Committee	Not Provided
Responsible Party	Bruno Gualano, University of Sao Paulo
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Sao Paulo
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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