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Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus

NCT01709474 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2015-12-17

Study results available
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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.

Conditions

Interventions

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.

DRUG

Vitamin D3 400 IU

Subjects will receive 400 IU/day of vitamin D3 daily by mouth.

Sponsors & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jon M Burnham, MD, MSCE · University of Pennsylvania

  • Emily Von Scheven, MD, MAS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709474 on ClinicalTrials.gov