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Creatine Supplementation in Pediatric Rheumatology

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Bruno Gualano, University of Sao Paulo.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo Identifier:
First received: October 6, 2010
Last updated: January 12, 2012
Last verified: January 2012
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.

Condition Intervention
Juvenile Systemic Lupus Erythematosus Juvenile Dermatomyositis Dietary Supplement: creatine Dietary Supplement: placebo (dextrose)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis

Resource links provided by NLM:

Further study details as provided by Bruno Gualano, University of Sao Paulo:

Primary Outcome Measures:
  • muscle strength [ Time Frame: after six months ]

Secondary Outcome Measures:
  • kidney function parameters [ Time Frame: after six months ]
  • quality of life [ Time Frame: after six months ]
  • muscle function [ Time Frame: after six months ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: creatine supplementation
will receive 5g/d of creatine monohydrate throughout the trial
Dietary Supplement: creatine
5g/d throughout 12 weeks
Placebo Comparator: placebo
will receive 5g/d of placebo (dextrose) throughout the trial
Dietary Supplement: placebo (dextrose)
5g/d throughout 12 weeks


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01217320

Contact: Bruno Gualano, PhD 551130913096

University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05508-30
Contact: Bruno Gualano, PhD   
Principal Investigator: Bruno Gualano, PhD         
Sponsors and Collaborators
University of Sao Paulo
Study Director: Bruno Gualano, PhD University of Sao Paulo
Study Director: Eloisa Bonfa, MD, PhD University of Sao Paulo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo Identifier: NCT01217320     History of Changes
Other Study ID Numbers: Cr in rheumato
Study First Received: October 6, 2010
Last Updated: January 12, 2012

Keywords provided by Bruno Gualano, University of Sao Paulo:
creatine supplementation
quality of life
juvenile systemic lupus erythematosus
juvenile dermatomyositis

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Skin Diseases processed this record on September 21, 2017