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

Phase 3

Active, not recruiting

• Conditions: Crohn Disease; Ulcerative Colitis; IBD
• Interventions: Drug: Vitamin D3

• Registration Number: NCT03162432
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Study Start: 2017-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-10
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D3 Treatment	Vitamin D3	Subjects receiving Remicade will be treated with oral Vitamin D3

Primary Outcome Measures

Name	Time	Method
Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range	Patients will continue to receive oral Vitamin D therapy for one year. We will be assessing the efficacy of oral Vitamin D therapy, in this dosing schema, to result in 25-OH Vitamin D levels during and at the conclusion of this one-year study.	The study will involve measuring serum 25-OH Vitamin D levels after the initiation of open-label therapy. This will be done approximately one month after starting therapy, at the end of the study interval (one year), and as clinically indicated over the course of the year. Serum 25-OH Vitamin D levels are the most robust metric for assessing Vitamin D sufficiency.

Secondary Outcome Measures

Name	Time	Method
Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D	Patients will be monitored for urinary symptoms and complete serial urine assessments as outlined in the protocol. The impact of oral Vitamin D administration on calcium excretion will be evaluated during and at the conclusion of this one-year study.	Patients will provide a spot urine collection the day prior to their Remicade infusion. A second spot urine collection will be collected on the day of the infusion. Urinary calcium excretion will be assessed. Changes in urinary calcium excretion will be used to identify subjects at risk for the development of renal stones.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States