Study Stopped
Difficulties with enrollment
Maintenance Dosing of Vitamin D in Crohn's Disease
A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission
1 other identifier
interventional
10
1 country
1
Brief Summary
Vitamin D repletion is important for bone health in patients with Crohn's disease. While repletion strategies in the general population yield similar results in those with Crohn's disease, maintenance strategies are variable. High quality evidence is lacking to determine the optimal strategy to maintain adequate levels of Vitamin D levels in patients with Crohn's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Aug 2018
Shorter than P25 for early_phase_1
1 active site
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
First Submitted
Initial submission to the registry
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedStudy Start
First participant enrolled
August 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedJuly 24, 2019
July 1, 2019
3 months
July 16, 2018
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Vitamin D serum level Vitamin D sufficiency
Serum level greater than or equal to 30 ng/ml
22 weeks
Secondary Outcomes (1)
Time to Vitamin D Insufficiency
22 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORVitamin D 1000 IU D3 daily
ACTIVE COMPARATORVitamin D 5000 IU D3 daily
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Crohn's disease
- In clinical remission as determined by the Harvey Bradshaw Index (CD) ≤4
- (OH)D level \<30 ng/ml within three months of study enrollment
- Prior 25(OH)D level \<30 ng/ml currently on repletion therapy
- Provided written informed consent
- years of age or older
- All maintenance therapies required to be on stable doses for 3 months.
You may not qualify if:
- Unwilling to provide consent or lack capacity
- Clinical disease activity (Harvey Bradshaw index \>4)
- Current pregnancy or attempting to conceive
- Hypercalcemia (must have calcium level within 6 months of enrollment)
- Known coexisting hyperparathyroidism
- BMI \>30 kg/m²
- History of kidney stones
- Subjects \<18 years of age - pediatric population with different recommended dosing than adults
- Non-english speakers
- Has an ileo-anal pouch or ileostomy
- C-reactive protein greater than 2x the upper limit of normal
- Lactose intolerant
- Short gut syndrome
- Renal insufficiency (CrCl \<60 ml/min)
- Concomitant therapy with thiazide diuretics, barbiturates, digitalis or supplemental products containing vitamin D
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
GIl Y Melmed, MD, MS
Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Director of Inflammatory Bowel Disease
Study Record Dates
First Submitted
July 16, 2018
First Posted
August 3, 2018
Study Start
August 30, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
July 24, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share
No information will be shared