High Dose Vitamin D3 in Crohn's Disease
Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000 International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's disease in remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedNovember 26, 2015
November 1, 2015
1.2 years
November 23, 2015
November 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in 25-OH vitamin D level
One year
Secondary Outcomes (4)
Clinical Remission (defined as Harvey-Bradshaw index <=4)
One year
Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS))
One year
Improvement in C-reactive protein
One year
Adverse events
One year
Study Arms (2)
High Dose Vitamin D3 (10,000 IU daily)
ACTIVE COMPARATORLow Dose Vitamin D3 (1000 IU daily)
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- a prior diagnosis of Crohn's disease in clinical remission for at least 28 days with a Harvey-Bradshaw index less than or equal to 4
- All maintenance therapies for Crohn's disease will be required to be at stable dose for at least 3 months before randomization, with no systemic steroid therapy within 4 weeks.
- Vitamin D supplements will be discontinued at least 6 weeks before randomization.
You may not qualify if:
- Women of child bearing potential who are considering pregnancy during the study period, currently pregnant, or unwilling to use contraception to avoid pregnancy
- Participants with renal insufficiency (serum creatinine greater than 150 umol/L), sarcoidosis, hyperparathyroidism, malignancy, or any other disorder that may lead to hypercalcemia
- Patients with short-gut syndrome or a serum albumin less than 32 g/L
- Concomitant therapy with thiazide diuretics, barbiturates, digitalis, or supplemental products containing vitamin D
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Canadian Association of Gastroenterologycollaborator
Related Publications (1)
Narula N, Cooray M, Anglin R, Muqtadir Z, Narula A, Marshall JK. Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn's Disease in Remission: A Pilot Randomized Double-Blind Controlled Study. Dig Dis Sci. 2017 Feb;62(2):448-455. doi: 10.1007/s10620-016-4396-7. Epub 2016 Dec 14.
PMID: 27975236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 26, 2015
Study Start
January 1, 2014
Primary Completion
March 1, 2015
Last Updated
November 26, 2015
Record last verified: 2015-11