Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749983
• Other study ID #: 0849/07
• Status: Completed
• Phase: N/A
• First received: September 9, 2008
• Last updated: October 1, 2012
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Knee Osteoarthritis
• Myofascial Pain Syndromes
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Creatine supplementation

• Dextrose supplementation

Locations

Country	Name	City	State
Brazil	University of Sao Paulo School of Medicine	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function	Assessed by the timed-stands test	12 weeks	No
Secondary	Strength	Assessed by the 1-repetition maximum test	12 weeks	No
Secondary	Quality of life	health-related questionaires	12 weeks	No
Secondary	Body composition	Assessed by DXA	12 weeks	No
Secondary	Renal function	Assessed by 51Cr-EDTA	12 weeks	Yes