Creatine Supplementation in Pediatric Rheumatology

NCT ID: NCT01217320

Last Updated: 2012-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Juvenile Systemic Lupus Erythematosus Juvenile Dermatomyositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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creatine supplementation

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

Group Type EXPERIMENTAL

creatine

Intervention Type DIETARY_SUPPLEMENT

5g/d throughout 12 weeks

placebo

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

Group Type PLACEBO_COMPARATOR

placebo (dextrose)

Intervention Type DIETARY_SUPPLEMENT

5g/d throughout 12 weeks

Interventions

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creatine

5g/d throughout 12 weeks

Intervention Type DIETARY_SUPPLEMENT

placebo (dextrose)

5g/d throughout 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Gualano, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Eloisa Bonfa, MD, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Bruno Gualano, PhD

Role: CONTACT

551130913096

Facility Contacts

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Bruno Gualano, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25135060 (View on PubMed)

Other Identifiers

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Cr in rheumato

Identifier Type: -

Identifier Source: org_study_id

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