High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

Recruiting

Conditions: Ulcerative Colitis
Crohn Disease
Vitamin D Deficiency
Inflammatory Bowel Disease

Registration Number: NCT04331639

Lead Sponsor: Boston Children's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria: - Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis - Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks - Age 5-25 years old, at study entry - Measured serum level of 25-OHD of less than 40 ng/mL in the last 4-8 weeks and no changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are evaluated routinely as part of standard clinical care for IBD Exclusion Criteria: - History of any underlying kidney disease - History of preexisting liver disease - History of granulomatous disease - Inability to take oral vitamin D3 as a pill - History of hypercalcemia or hypercalciuria - Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vitamin D target

Secondary Outcome Measures

Name	Time	Method
change in vitamin D level;vitamin D binding protein;parathyroid hormone;serum safety parameter;urine safety parameter;bone mineral density;markers of bone turnover;inflammatory bowel disease treatment parameters;cytokine measurements;c-reactive protein;erythrocyte sedimentation rate;health-related quality of life questionnaire for inflammatory bowel disease;baseline questionnaire on overall health;fracture history questionnaire;food frequency questionnaire;physical activity questionnaire;sun exposure questionnaire;follow-up questionnaire on overall health