High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade

Boston Children's Hospital

Status and phase: Active, not recruiting; Phase 3

Conditions: Ulcerative Colitis; IBD; Crohn Disease

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT03162432

IND 135093

Details and patient eligibility

About

The goal of this study will be to assess the safety and efficacy of high-dose interval Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated with serial Remicade infusions.

Full description

Study subjects will receiving 50,000 units of Vitamin D3 if they receive Remicade infusions every 4-6 weeks. Study subjects will receiving 100,000 units of Vitamin D3 if they receive Remicade infusions every 6-8 weeks.

Enrollment: 50 estimated patients

Sex: All

Ages: 7 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Existing diagnosis of IBD
• Age 0-25 years
• Measured serum level of 25-OH Vitamin D of 15-29 ng/ml in the last 8 weeks and no changes in Vitamin D supplementation in the interim

Exclusion criteria

• Pregnant Women
• History of underlying kidney disease
• History of granulomatous disease
• Inability to take oral Vitamin D
• History of hypercalcemia or hypercalciuria
• Currently taking an anti-epileptic medication
• History of pre-existing liver disease (excluding primary sclerosing cholangitis, non-alcoholic fatty liver disease, or steatohepatitis)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Vitamin D3 Treatment

Experimental group

Description:

Subjects receiving Remicade will be treated with oral Vitamin D3

Treatment:

Drug: Vitamin D3