Study Stopped
Due to slow enrollment
Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus
Vitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE)
1 other identifier
interventional
7
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2013
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
December 3, 2015
CompletedDecember 17, 2015
December 1, 2015
1.1 years
October 16, 2012
October 20, 2015
December 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Average IFN Module Expression Level
No mechanistic analyses were performed due to recruitment feasibility issues.
Baseline to Week 18
Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3
Adverse event grading based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0
Baseline to 18 Weeks
Study Arms (2)
Vitamin D3 6000 IU
EXPERIMENTAL6000 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.
Vitamin D3 400 IU
ACTIVE COMPARATOR400 IU/day of vitamin D3 by mouth daily.
Interventions
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.
Subjects will receive 400 IU/day of vitamin D3 daily by mouth.
Eligibility Criteria
You may qualify if:
- Written informed consent signed by the subject or parent/guardian as appropriate; child assent as appropriate;
- Before the age of 19, met at least 4 of the 11 modified American College of Rheumatology (ACR) 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus as updated in 1997;
- Serum 25-hydroxyvitamin D \[25(OH)D\] \< 20 ng/mL at Screening;
- SELENA SLEDAI score \> 0 and \< 8 at Screening and at Baseline;
- If taking prednisone (or equivalent corticosteroid), the dose must be ≤ 15 mg/day or ≤0.5 mg/kg/day, whichever is lower, and stable for at least four weeks prior to randomization. Note, if subjects are taking steroids every other day, divide their dose by 2 to evaluate eligibility;
- Stable immunosuppressive dose for at least 12 weeks prior to randomization;
- Immunosuppressive medications allowed include mycophenolate (MMF), azathioprine, methotrexate, antimalarial medications (e.g., hydroxychloroquine), cyclosporine A (CsA), tacrolimus, intravenous immune globulin (IVIG), and abatacept.
- Body weight \> 25 kg;
- Able to swallow pills;
- Males and females with reproductive potential must agree to practice effective measures of birth control.
You may not qualify if:
- Any condition or treatment that, in the opinion of the investigator, places the subject at an unacceptable risk as a participant in the trial;
- Current pharmacologic vitamin D2 or D3 intake \> 800 IU daily or use of calcitriol at any dose over the past four weeks prior to randomization;
- Cyclophosphamide or IV glucocorticoid exposure within 12 weeks prior to randomization;
- Any BILAG A or B manifestation with the exception of a BILAG B mucocutaneous manifestation at screening, and excluding the renal BILAG criteria (see rituximab or belimumab criterion, below);
- Significant renal insufficiency defined as:
- Estimated GFR \< 60 mL/min/1.73m\^2 or estimated GFR \< 90 mL/min/1.73m\^2 with a reduction of the GFR by \> 15% from the last measurement;
- Urine dipstick value of 2+ or higher for protein, unless this is a stable value from the last measurement or, urine protein-creatinine ratio ≥ 50 mg/mmol unless the value represents an improvement of ≥ 25% from the last measurement.
- Rituximab or belimumab exposure use within 24 weeks prior to randomization;
- The following laboratory parameters at the Screening visit:
- Platelets \< 50,000; WBC \< 2,500; ANC \< 1,000;
- Hemoglobin \< 9 mg/dL;
- ALT, AST, bilirubin \> 2x upper limit of normal (ULN);
- Hypercalcemia (calcium \> ULN);
- Hypercalciuria (urinary calcium/creatinine ratio \> 0.2).
- Primary hyperparathyroidism (known);
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Lucile Packard Children's Hospital, Stanford University
Palo Alto, California, 94304, United States
UCSF School of Medicine
San Francisco, California, 94143, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Columbia University
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Seattle Children's Hospital
Seattle, Washington, 98101, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study terminated early due to recruitment feasibility issues. Seven subjects were enrolled and received treatment in contrast to the planned number of 78 subjects for randomization/receipt of treatment. No mechanistic analyses were performed.
Results Point of Contact
- Title
- Director, Clinical Research Operations Program
- Organization
- DAIT/NIAID
Study Officials
- STUDY CHAIR
Jon M Burnham, MD, MSCE
University of Pennsylvania
- STUDY CHAIR
Emily Von Scheven, MD, MAS
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2012
First Posted
October 18, 2012
Study Start
June 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
December 17, 2015
Results First Posted
December 3, 2015
Record last verified: 2015-12