High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
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|ClinicalTrials.gov Identifier: NCT03162432|
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|IBD Ulcerative Colitis Crohn Disease||Drug: Vitamin D3||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 1, 2020|
Experimental: Vitamin D3 Treatment
Subjects receiving Remicade will be treated with oral Vitamin D3
Drug: Vitamin D3
Oral Vitamin D3 therapy.
- Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range [ Time Frame: 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.
- Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162432
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|