Creatine Supplementation in Pediatric Rheumatology
Primary Purpose
Juvenile Systemic Lupus Erythematosus, Juvenile Dermatomyositis
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
creatine
placebo (dextrose)
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Systemic Lupus Erythematosus focused on measuring rheumatology, creatine supplementation, quality of life, strength, juvenile systemic lupus erythematosus, juvenile dermatomyositis
Eligibility Criteria
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
Sites / Locations
- University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
creatine supplementation
placebo
Arm Description
will receive 5g/d of creatine monohydrate throughout the trial
will receive 5g/d of placebo (dextrose) throughout the trial
Outcomes
Primary Outcome Measures
muscle strength
Secondary Outcome Measures
kidney function parameters
quality of life
muscle function
Full Information
NCT ID
NCT01217320
First Posted
October 6, 2010
Last Updated
January 12, 2012
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01217320
Brief Title
Creatine Supplementation in Pediatric Rheumatology
Official Title
Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Systemic Lupus Erythematosus, Juvenile Dermatomyositis
Keywords
rheumatology, creatine supplementation, quality of life, strength, juvenile systemic lupus erythematosus, juvenile dermatomyositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
creatine supplementation
Arm Type
Experimental
Arm Description
will receive 5g/d of creatine monohydrate throughout the trial
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
will receive 5g/d of placebo (dextrose) throughout the trial
Intervention Type
Dietary Supplement
Intervention Name(s)
creatine
Intervention Description
5g/d throughout 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo (dextrose)
Intervention Description
5g/d throughout 12 weeks
Primary Outcome Measure Information:
Title
muscle strength
Time Frame
after six months
Secondary Outcome Measure Information:
Title
kidney function parameters
Time Frame
after six months
Title
quality of life
Time Frame
after six months
Title
muscle function
Time Frame
after six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Gualano, PhD
Phone
551130913096
Email
gualano@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eloisa Bonfa, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-30
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD
Email
gualano@usp.br
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
25135060
Citation
Hayashi AP, Solis MY, Sapienza MT, Otaduy MC, de Sa Pinto AL, Silva CA, Sallum AM, Pereira RM, Gualano B. Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial. Lupus. 2014 Dec;23(14):1500-11. doi: 10.1177/0961203314546017. Epub 2014 Aug 18.
Results Reference
derived
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Creatine Supplementation in Pediatric Rheumatology
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