Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus
|Systemic Lupus Erythematosus||Drug: Vitamin D3 6000 IU Drug: Vitamin D3 400 IU||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE)|
- Change in Average IFN Module Expression Level [ Time Frame: Baseline to Week 18 ]No mechanistic analyses were performed due to recruitment feasibility issues.
- Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3 [ Time Frame: Baseline to 18 Weeks ]Adverse event grading based on National Cancer Institute— Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0
|Study Start Date:||June 2013|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D3 6000 IU
6000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose is reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week.
Drug: Vitamin D3 6000 IU
Subjects will receive 6,000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose will be reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week.
Active Comparator: Vitamin D3 400 IU
400 IU/day of vitamin D3 by mouth daily.
Drug: Vitamin D3 400 IU
Subjects will receive 400 IU/day of vitamin D3 daily by mouth.
This is a multi-center, phase II, 18-week, two arm, unblinded randomized clinical trial.
Seventy-eight pediatric subjects with SLE and 25(OH)D levels ≤ 20 ng/mL will be randomized in a 1:1 ratio to receive either standard-dose (400 IU/day) or high-dose (6,000 IU/day) vitamin D3 for 18 weeks based upon weight at baseline. Subjects randomized to the high-dose vitamin D3 treatment arm will receive 6,000 IU per day from baseline until the subject's vitamin D levels reach ≥ 40 ng/mL at which point the vitamin D3 dose will be reduced to 4,000 IU per day. Subjects randomized to the high-dose treatment arm weighing < 40 kg will receive supplementation five days per week and all other subjects will receive supplementation seven days a week.
In addition to the baseline, and weeks 6, 12, and 18 visits, subjects randomized to the high-dose treatment arm will return at Weeks 3 and 9 to assess for symptoms of vitamin D toxicity. If a subject in the high-dose arm is found to exhibit evidence of vitamin D toxicity at the week 12 visit, he/she will be asked to return to their clinical research site for an additional vitamin D toxicity assessment at week 15. Study personnel will record each subject's interval history, assess adverse events, disease activity, and collect samples for safety and mechanistic assessments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709474
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Lucile Packard Children's Hospital, Stanford University|
|Palo Alto, California, United States, 94304|
|UCSF School of Medicine|
|San Francisco, California, United States, 94143|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|New York, New York, United States, 10032|
|University of Rochester|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Children's Medical Center of Dallas|
|Dallas, Texas, United States, 75235|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98101|
|Study Chair:||Jon M Burnham, MD, MSCE||University of Pennsylvania|
|Study Chair:||Emily Von Scheven, MD, MAS||University of California, San Francisco|