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Maintenance Dosing of Vitamin D in Crohn's Disease

Primary Purpose

Crohns Disease, Vitamin D Deficiency

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
5000 IU D3
1000 IU D3
Placebo
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohns Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Vitamin D 1000 IU D3 daily

Vitamin D 5000 IU D3 daily

Arm Description

Outcomes

Primary Outcome Measures

Vitamin D serum level Vitamin D sufficiency
Serum level greater than or equal to 30 ng/ml

Secondary Outcome Measures

Time to Vitamin D Insufficiency
Time (in weeks) from the measurement of sufficiency (at week 0) to Vitamin D insufficiency (defined as serum vitamin D level less than 30 ng/mL)

Full Information

First Posted
July 16, 2018
Last Updated
July 22, 2019
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03615378
Brief Title
Maintenance Dosing of Vitamin D in Crohn's Disease
Official Title
A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulties with enrollment
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators seek to identify patients with Crohn's disease in clinical remission who have vitamin D levels <30 ng/ml. Subjects will undergo a 8 week lead in period and receive Vitamin D supplementation with 50,000 IU D2 weekly for 8 weeks.Participants with sufficient Vitamin D levels after 8 weeks (>30 ng/mL) will be enrolled into the study and randomized to one of three arms: (1) placebo (2) 1000 IU/day Vitamin D3 (3) 5,000 IU/day Vitamin D3 for 22 weeks. Based on clinical experience, doses higher than the recommended doses for bone health in the general population (600-800 IU/day Vitamin D3) are needed to achieve and maintain optimal levels of Vitamin D in people with Crohn's disease. The investigators aim to determine optimal maintenance dosing to sustain vitamin D sufficiency in people with Crohn's disease. The investigators also seek to determine demographic and disease related characteristics associated with inability to maintain sufficient levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohns Disease, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Vitamin D 1000 IU D3 daily
Arm Type
Active Comparator
Arm Title
Vitamin D 5000 IU D3 daily
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
5000 IU D3
Intervention Description
Daily
Intervention Type
Dietary Supplement
Intervention Name(s)
1000 IU D3
Intervention Description
Daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
lactose/sugar tablet
Primary Outcome Measure Information:
Title
Vitamin D serum level Vitamin D sufficiency
Description
Serum level greater than or equal to 30 ng/ml
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Time to Vitamin D Insufficiency
Description
Time (in weeks) from the measurement of sufficiency (at week 0) to Vitamin D insufficiency (defined as serum vitamin D level less than 30 ng/mL)
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Crohn's disease In clinical remission as determined by the Harvey Bradshaw Index (CD) ≤4 25(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 18 years of age or older All maintenance therapies required to be on stable doses for 3 months. Exclusion Criteria: 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 Vitamin D levels <30ng/ml at completion of lead in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GIl Y Melmed, MD, MS
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No information will be shared

Learn more about this trial

Maintenance Dosing of Vitamin D in Crohn's Disease

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