Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00749983
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Fibromyalgia	Dietary Supplement: Creatine supplementation; Dietary Supplement: Dextrose supplementation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 creatine intake	Dietary Supplement: Creatine supplementation
Placebo Comparator: 2 placebo (dextrose) intake	Dietary Supplement: Dextrose supplementation

Outcome Measures

Primary Outcome Measures

1. Physical function [12 weeks]

   Assessed by the timed-stands test

Secondary Outcome Measures

1. Strength [12 weeks]

   Assessed by the 1-repetition maximum test

2. Quality of life [12 weeks]

   health-related questionaires

3. Body composition [12 weeks]

   Assessed by DXA

4. Renal function [12 weeks]

   Assessed by 51Cr-EDTA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Sao Paulo School of Medicine	Sao Paulo		Brazil	01246903

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT00749983
• Other Study ID Numbers: 0849/07
• First Posted: Sep 10, 2008
• Last Update Posted: Oct 2, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Fibromyalgia; Myofascial Pain Syndromes

Study Results

No Results Posted as of Oct 2, 2012