Status:
COMPLETED
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
Lead Sponsor:
ROSA MARIA RODRIGUES PEREIRA
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
10-25 years
Phase:
NA
Brief Summary
The potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Although...
Detailed Description
This is a study 24-week, two arm, double blinded randomized clinical trial to evaluate the effects of high-dose vitamin D3 supplementation compared with placebo, on activity disease, fatigue and bone ...
Eligibility Criteria
Inclusion
- Written informed consent signed
- 4 of the 11 modified American College of Rheumatology (ACR) Revised Criteria for the Classification of Systemic Lupus Erythematosus .
- SLEDAI \< 8 at Screening and at Baseline
- Stable immunosuppressive dose prior to randomization.
- Body Mass Index \< 30
- Able to swallow pills at randomization
Exclusion
- Refuse of the patient or the legal responsible
- Use of vitamin D2 or D3 supplementation
- Significant renal insufficiency
- Primary hyperparathyroidism (known)
- History of nephrolithiasis (known)
- Diabetes mellitus requiring insulin therapy
- History of vertebral compression fractures (known)
- Pregnancy
- Use of bisphosphonates
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01892748
Start Date
July 1 2012
End Date
February 1 2014
Last Update
May 12 2016
Active Locations (1)
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1
University of Sao Paulo - School of Medicine
São Paulo, São Paulo, Brazil, 01246-903