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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03615378 |
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Date of registration:
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16/07/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Maintenance Dosing of Vitamin D in Crohn's Disease
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Scientific title:
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A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission |
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Date of first enrolment:
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August 30, 2018 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03615378 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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GIl Y Melmed, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cedars-Sinai Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of Crohn's disease
2. In clinical remission as determined by the Harvey Bradshaw Index (CD) =4
3. 25(OH)D level <30 ng/ml within three months of study enrollment
4. Prior 25(OH)D level <30 ng/ml currently on repletion therapy
5. Provided written informed consent
6. 18 years of age or older
7. All maintenance therapies required to be on stable doses for 3 months.
Exclusion Criteria:
1. Unwilling to provide consent or lack capacity
2. Clinical disease activity (Harvey Bradshaw index >4)
3. Current pregnancy or attempting to conceive
4. Hypercalcemia (must have calcium level within 6 months of enrollment)
5. Known coexisting hyperparathyroidism
6. BMI >30 kg/m²
7. History of kidney stones
8. Subjects <18 years of age - pediatric population with different recommended dosing
than adults
9. Non-english speakers
10. Has an ileo-anal pouch or ileostomy
11. C-reactive protein greater than 2x the upper limit of normal
12. Lactose intolerant
13. Short gut syndrome
14. Renal insufficiency (CrCl <60 ml/min)
15. Concomitant therapy with thiazide diuretics, barbiturates, digitalis or supplemental
products containing vitamin D
16. Vitamin D levels <30ng/ml at completion of lead in
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohns Disease
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Vitamin D Deficiency
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: 1000 IU D3
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Dietary Supplement: 5000 IU D3
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Primary Outcome(s)
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Vitamin D serum level Vitamin D sufficiency
[Time Frame: 22 weeks]
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Secondary Outcome(s)
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Time to Vitamin D Insufficiency
[Time Frame: 22 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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