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Creatine Supplementation in Pediatric Rheumatology

U

University of Sao Paulo

Status

Unknown

Conditions

Juvenile Systemic Lupus Erythematosus
Juvenile Dermatomyositis

Treatments

Dietary Supplement: placebo (dextrose)
Dietary Supplement: creatine

Study type

Interventional

Funder types

Other

Identifiers

NCT01217320
Cr in rheumato

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

creatine supplementation
Experimental group
Description:
will receive 5g/d of creatine monohydrate throughout the trial
Treatment:
Dietary Supplement: creatine
placebo
Placebo Comparator group
Description:
will receive 5g/d of placebo (dextrose) throughout the trial
Treatment:
Dietary Supplement: placebo (dextrose)

Trial contacts and locations

1

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Central trial contact

Bruno Gualano, PhD

Data sourced from clinicaltrials.gov

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