Creatine Supplementation in Pediatric Rheumatology

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01217320
First received: October 6, 2010
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Sao Paulo:

Primary Outcome Measures:
  • muscle strength [ Time Frame: after six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • kidney function parameters [ Time Frame: after six months ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: after six months ] [ Designated as safety issue: No ]
  • muscle function [ Time Frame: after six months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01217320     History of Changes
Other Study ID Numbers: Cr in rheumato
Study First Received: October 6, 2010
Last Updated: January 12, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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
Myositis
Muscular Diseases
Musculoskeletal Diseases
Polymyositis
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 31, 2014