Creatine Supplementation in Pediatric Rheumatology

Juvenile Dermatomyositis Clinical Trial

Official title:

Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01217320
• Other study ID #: Cr in rheumato
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2010
• Last updated: January 12, 2012
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2012
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: 551130913096
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Dermatomyositis
• Juvenile Dermatomyositis
• Juvenile Systemic Lupus Erythematosus
• Lupus Erythematosus, Systemic

Intervention

Dietary Supplement:
• creatine
5g/d throughout 12 weeks
• placebo (dextrose)
5g/d throughout 12 weeks

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle strength		after six months	No
Secondary	kidney function parameters		after six months	Yes
Secondary	quality of life		after six months	No
Secondary	muscle function		after six months	No