- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01217320
Creatine Supplementation in Pediatric Rheumatology
January 12, 2012 updated by: Bruno Gualano, University of Sao Paulo
Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis
Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in healthy and elderly people.
The investigators speculate that creatine supplementation could have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting and bone mass loss.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
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 Contact
- Name: Bruno Gualano, PhD
- Phone Number: 551130913096
- Email: gualano@usp.br
Study Locations
-
-
-
Sao Paulo, Brazil, 05508-30
- Recruiting
- University of Sao Paulo
-
Contact:
- Bruno Gualano, PhD
- Email: gualano@usp.br
-
-
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
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis
- physically inactive
- stable pharmacological treatment
Exclusion Criteria:
- macroalbuminuria
- GFR < 30 mL/min/1.73m2
- use of oral anticontraceptive agents
- pregnancy
- diabetes mellitus
- hypothyroidism
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: creatine supplementation
will receive 5g/d of creatine monohydrate throughout the trial
|
5g/d throughout 12 weeks
|
Placebo Comparator: placebo
will receive 5g/d of placebo (dextrose) throughout the trial
|
5g/d throughout 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle strength
Time Frame: after six months
|
after six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
kidney function parameters
Time Frame: after six months
|
after six months
|
quality of life
Time Frame: after six months
|
after six months
|
muscle function
Time Frame: after six months
|
after six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bruno Gualano, PhD, University of Sao Paulo
- Study Director: Eloisa Bonfa, MD, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2011
Primary Completion (Anticipated)
September 1, 2012
Study Completion (Anticipated)
September 1, 2012
Study Registration Dates
First Submitted
October 6, 2010
First Submitted That Met QC Criteria
October 7, 2010
First Posted (Estimate)
October 8, 2010
Study Record Updates
Last Update Posted (Estimate)
January 16, 2012
Last Update Submitted That Met QC Criteria
January 12, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cr in rheumato
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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George Washington UniversityCompleted
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