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Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749983
First Posted: September 10, 2008
Last Update Posted: October 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
  Purpose
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 Intervention
Knee Osteoarthritis Fibromyalgia Dietary Supplement: Creatine supplementation Dietary Supplement: Dextrose supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bruno Gualano, University of Sao Paulo:

Primary Outcome Measures:
  • Physical function [ Time Frame: 12 weeks ]
    Assessed by the timed-stands test


Secondary Outcome Measures:
  • Strength [ Time Frame: 12 weeks ]
    Assessed by the 1-repetition maximum test

  • Quality of life [ Time Frame: 12 weeks ]
    health-related questionaires

  • Body composition [ Time Frame: 12 weeks ]
    Assessed by DXA

  • Renal function [ Time Frame: 12 weeks ]
    Assessed by 51Cr-EDTA


Enrollment: 60
Study Start Date: June 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
creatine intake
Dietary Supplement: Creatine supplementation
Placebo Comparator: 2
placebo (dextrose) intake
Dietary Supplement: Dextrose supplementation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749983


Locations
Brazil
University of Sao Paulo School of Medicine
Sao Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo
  More Information

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00749983     History of Changes
Other Study ID Numbers: 0849/07
First Submitted: September 9, 2008
First Posted: September 10, 2008
Last Update Posted: October 2, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Osteoarthritis
Fibromyalgia
Myofascial Pain Syndromes
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases