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Creatine Supplementation in Pediatric Rheumatology

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ClinicalTrials.gov Identifier: NCT01217320
Recruitment Status : Unknown
Verified January 2012 by Bruno Gualano, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : October 8, 2010
Last Update Posted : January 16, 2012
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, 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.

Condition or disease Intervention/treatment Phase
Juvenile Systemic Lupus Erythematosus Juvenile Dermatomyositis Dietary Supplement: creatine Dietary Supplement: placebo (dextrose) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. kidney function parameters [ Time Frame: after six months ]
  2. quality of life [ Time Frame: after six months ]
  3. muscle function [ Time Frame: after six months ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217320


Contacts
Contact: Bruno Gualano, PhD 551130913096 gualano@usp.br

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05508-30
Contact: Bruno Gualano, PhD       gualano@usp.br   
Principal Investigator: Bruno Gualano, PhD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Bruno Gualano, PhD University of Sao Paulo
Study Director: Eloisa Bonfa, MD, PhD University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01217320     History of Changes
Other Study ID Numbers: Cr in rheumato
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: January 16, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Dermatomyositis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Skin Diseases