Juvenile Systemic Lupus ErythematosusNCT01217320
Creatine Supplementation in Pediatric Rheumatology
A study testing creatine in people with Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Juvenile Systemic Lupus Erythematosus, Juvenile Dermatomyositis
- What is being tested?
- creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis
- physically inactive
- stable pharmacological treatment
Who cannot join
- macroalbuminuria
- GFR < 30 mL/min/1.73m2
- use of oral anticontraceptive agents
- pregnancy
- diabetes mellitus
- hypothyroidism
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, São Paulo, 05508-30
Bruno Gualano, PhD, gualano@usp.br
Bruno Gualano, PhD
About this study
Official title: Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis
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.
- Being tested
- creatine, placebo (dextrose)
- Keywords
- rheumatology, creatine supplementation, quality of life, strength, juvenile systemic lupus erythematosus, juvenile dermatomyositis
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatineDietary supplement
5g/d throughout 12 weeks
placebo (dextrose)Dietary supplement
5g/d throughout 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| creatine supplementation | Experimental | will receive 5g/d of creatine monohydrate throughout the trial Receives: Dietary Supplement: creatine |
| placebo | Placebo comparator | will receive 5g/d of placebo (dextrose) throughout the trial Receives: Dietary Supplement: placebo (dextrose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
Measured: after six months
Secondary outcomes (3)
kidney function parameters
Measured: after six months
quality of life
Measured: after six months
muscle function
Measured: after six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Bruno Gualano, PhD, Study director, University of Sao PauloEloisa Bonfa, MD, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217320
- Sponsor's protocol ID
- Cr in rheumato
- Status last verified
- Jan 2012
- First submitted
- 6 Oct 2010
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25135060
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis
- ClinicalTrials.gov ID
- NCT01217320
- Acronym / sponsor ID
- Cr in rheumato
- Keywords
- rheumatology, creatine supplementation, quality of life, strength, juvenile systemic lupus erythematosus, juvenile dermatomyositis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| creatine supplementation | Experimental | Dietary Supplement: creatinewill receive 5g/d of creatine monohydrate throughout the trial |
| placebo | Placebo comparator | Dietary Supplement: placebo (dextrose)will receive 5g/d of placebo (dextrose) throughout the trial |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis
- physically inactive
- stable pharmacological treatment
Key exclusion criteria (6 listed)
- macroalbuminuria
- GFR < 30 mL/min/1.73m2
- use of oral anticontraceptive agents
- pregnancy
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| creatine5g/d throughout 12 weeks | Dietary supplement | creatine supplementation |
| placebo (dextrose)5g/d throughout 12 weeks | Dietary supplement | placebo |
Primary outcome
muscle strength
Time frame: after six months
3 secondary outcomes
kidney function parameters
Time frame: after six months
quality of life
Time frame: after six months
muscle function
Time frame: after six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
- Derived from this study: PubMed 25135060Hayashi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Gualano, PhD study director
University of Sao Paulo
Eloisa Bonfa, MD, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creatine in people with Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, PhD (551130913096, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: after six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2012.