drugset / Trial / NCT01709474
Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus
Phase 2
Terminated
7 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the effects of 18 weeks of high-dose vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune function, glucose homeostasis, and bone metabolism in children with systemic lupus erythematosus (SLE) and serum 25-hydroxyvitamin D \[25(OH)D\] levels ≤20 ng/mL.
Timeline
- Start
- 2013-06
- Primary completion
- 2014-07
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 400 iu | Oral |
| Subject | Cholecalciferol | Other / unclassified | 6000 iu | Oral |