NCT01217320

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

1.7 years

First QC Date

October 6, 2010

Last Update Submit

January 12, 2012

Conditions

Juvenile Systemic Lupus ErythematosusJuvenile Dermatomyositis

Keywords

rheumatologycreatine supplementationquality of lifestrengthjuvenile systemic lupus erythematosusjuvenile dermatomyositis

Outcome Measures

Primary Outcomes (1)

  • muscle strength

    after six months

Secondary Outcomes (3)

  • kidney function parameters

    after six months

  • quality of life

    after six months

  • muscle function

    after six months

Study Arms (2)

creatine supplementation

EXPERIMENTAL

will receive 5g/d of creatine monohydrate throughout the trial

Dietary Supplement: creatine

placebo

PLACEBO COMPARATOR

will receive 5g/d of placebo (dextrose) throughout the trial

Dietary Supplement: placebo (dextrose)

Interventions

creatineDIETARY_SUPPLEMENT

5g/d throughout 12 weeks

creatine supplementation
placebo (dextrose)DIETARY_SUPPLEMENT

5g/d throughout 12 weeks

placebo

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis
  • physically inactive
  • stable pharmacological treatment

You may not qualify if:

  • macroalbuminuria
  • GFR \< 30 mL/min/1.73m2
  • use of oral anticontraceptive agents
  • pregnancy
  • diabetes mellitus
  • hypothyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-30, Brazil

RECRUITING

Related Publications (1)

  • Hayashi AP, Solis MY, Sapienza MT, Otaduy MC, de Sa Pinto AL, Silva CA, Sallum AM, Pereira RM, Gualano B. Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial. Lupus. 2014 Dec;23(14):1500-11. doi: 10.1177/0961203314546017. Epub 2014 Aug 18.

    PMID: 25135060DERIVED

MeSH Terms

Conditions

Dermatomyositis

Interventions

CreatineGlucose

Condition Hierarchy (Ancestors)

PolymyositisMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Bruno Gualano, PhD

    University of Sao Paulo

    STUDY DIRECTOR

  • Eloisa Bonfa, MD, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Central Study Contacts

Bruno Gualano, PhD

CONTACT

551130913096gualano@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 8, 2010

Study Start

January 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 16, 2012

Record last verified: 2012-01

Locations

BR(1)