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NCT04331639 · ClinicalTrials.gov registry record
High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
A clinical trial of Ulcerative Colitis and Crohn Disease, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT04331639: Recruiting study of Ulcerative Colitis and Crohn Disease, sponsored by Boston Children's Hospital.
NCT04331639 is a study of Ulcerative Colitis and Crohn Disease that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 50 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04331639, a study of Ulcerative Colitis and Crohn Disease, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.
Primary Outcome
assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT vitamin D3
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-11-01 |
| Est. Completion | 2025-12-31 |
What NCT04331639 shows while recruiting
NCT04331639 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which vitamin D3 is the first listed.
NCT04331639 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04331639 about?
NCT04331639 is a clinical study titled "High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy". The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.
What is the current status of trial NCT04331639?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2020-11-01. Estimated completion is 2025-12-31.
What conditions does trial NCT04331639 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease, Vitamin D Deficiency, Inflammatory Bowel Disease.
What interventions are being tested in trial NCT04331639?
The interventions under investigation include: vitamin D3 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04331639?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04331639 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04331639's enrollment target sits among peer trials
50 87th of 122 higher than 35 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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