Creatine Supplementation in Pediatric Rheumatology

Not Applicable

• Conditions: Juvenile Dermatomyositis; Juvenile Systemic Lupus Erythematosus

• Registration Number: NCT01217320
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Study Start: 2011-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-12
• Last Update Posted: 2012-01-16
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
muscle strength	after six months

Secondary Outcome Measures

Name	Time	Method
muscle function	after six months
quality of life	after six months
kidney function parameters	after six months

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil