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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Physical function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessed by the timed-stands test


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   25 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749983

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

No publications provided

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00749983     History of Changes
Other Study ID Numbers: 0849/07
Study First Received: September 9, 2008
Last Updated: October 1, 2012
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on June 18, 2013