Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

October 1, 2012 updated by: Bruno Gualano, University of Sao Paulo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01246903
        • University of Sao Paulo School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
creatine intake
Dietary supplement: Creatine supplementation
PLACEBO_COMPARATOR: 2
placebo (dextrose) intake
Dietary supplement: Dextrose supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function
Time Frame: 12 weeks
Assessed by the timed-stands test
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength
Time Frame: 12 weeks
Assessed by the 1-repetition maximum test
12 weeks
Quality of life
Time Frame: 12 weeks
health-related questionaires
12 weeks
Body composition
Time Frame: 12 weeks
Assessed by DXA
12 weeks
Renal function
Time Frame: 12 weeks
Assessed by 51Cr-EDTA
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (ESTIMATE)

September 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0849/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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