Vitamin D Repletion and Maintenance in IBD: How Much and How Often
Primary Purpose
Inflammatory Bowel Diseases, Vitamin D Deficiency
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D (ergocalciferol and/ or cholecalciferol)
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Crohn's disease or Ulcerative colitis
- In clinical remission or with mild disease activity as determined by the Harvey Bradshaw Index (CD) ≤7 or Ulcerative Colitis disease activity index ≤6.
- 25(OH)D level <30 ng/ml within three months of study enrollment
- Provided verbal consent
- 18 years of age or older
Exclusion Criteria:
- Unwilling to provide consent or lack capacity
- Moderate to severe disease activity (Harvey Bradshaw index >7 or UCDAI >6)
- Current pregnancy or attempting to conceive
- Known coexisting hyperparathyroidism
- Already on vitamin D supplementation, calcium supplementation or a multivitamin
- BMI >30 kg/m²
- History of kidney stones
- Subjects <18 years of age - pediatric population with different recommended dosing than adults (10).
- Non-english speakers
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Treatment Arm # 1
Treatment Arm # 2
Treatment Arm # 3
Treatment Arm # 4
Arm Description
50,000 IU oral vitamin D2 per week for 12 weeks + Dietary counseling
50,000 IU oral vitamin D2 per week x 12 weeks then 800 IU/day oral vitamin D3 for 6 months + Dietary counseling
50,000 IU oral vitamin D2 per week x 12 weeks then 5,000 IU/day oral vitamin D3 for 6 months+ Dietary counseling
5,000 IU oral daily vitamin D3 for 9 months + Dietary counseling
Outcomes
Primary Outcome Measures
Vitamin D levels after completion of repletion dosing
Secondary Outcome Measures
Vitamin D levels on maintenance dosing
Full Information
NCT ID
NCT03053414
First Posted
February 6, 2017
Last Updated
March 19, 2018
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03053414
Brief Title
Vitamin D Repletion and Maintenance in IBD: How Much and How Often
Official Title
A Vitamin D Dosing Strategy for Adequate Repletion and Maintenance in IBD Patients With Minimal Disease Activity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
change in study design before recruitment began
Study Start Date
February 20, 2017 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), are chronic relapsing inflammatory conditions of the gastrointestinal tract. IBD is thought to result from a complex interaction between genetic, immune, microbial and environmental factors. There is emerging data suggesting Vitamin D may not only play a role in bone health but may also be involved in gut health as well. While there are guidelines regarding the recommending doses of Vitamin D for supplementation and maintenance in bone health, these strategies are unknown in those with inflammatory bowel disease. The investigators seek to determine a dosing strategy for this population using doses within the recommended guidelines for bone health.
Detailed Description
Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), are chronic relapsing inflammatory conditions of the gastrointestinal tract. IBD is thought to result from a complex interaction between genetic, immune, microbial and environmental factors. The role of vitamin D in bone health and calcium homeostasis is well documented. However, emerging data suggests that vitamin D may also regulate immune responses, which may play a role in the pathogenesis and disease activity of IBD.
The investigators seek to identify CD or UC patients with mild disease or in clinical remission who have vitamin D levels <30 ng/ml and not on any type of vitamin repletion therapy. The investigators will randomize the participants into one of four arms: (1) Oral 50,000 vitamin D IU every week for 12 weeks (2) Oral 50,000 vitamin D weekly for 12 weeks than oral 800 vitamin D IU/d (3) Oral 50,000 vitamin D IU weekly for 12 weeks then 5,000 vitamin D IU/d (4) Oral 5,000 vitamin D IU/d and check vitamin D levels and inflammatory markers as part of standard of care follow- up every 3 months for nine months. Every participant will receive dietary counseling throughout the study duration. Our aim is to identify an optimal dosing strategy for repletion and maintenance of vitamin D levels in the subset of IBD patients. Based on clinical experience, doses higher than the recommended doses for bone health are needed to achieve and maintain optimal levels of Vitamin D in IBD patients, even patients are in remission or do not have small bowel (malabsorption) involvement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to one of four treatment arms for the duration of the study. Labs will be checked every 3 months as part of standard of care to help delineate the best strategy for repletion and maintenance of Vitamin D levels throughout the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm # 1
Arm Type
Active Comparator
Arm Description
50,000 IU oral vitamin D2 per week for 12 weeks + Dietary counseling
Arm Title
Treatment Arm # 2
Arm Type
Active Comparator
Arm Description
50,000 IU oral vitamin D2 per week x 12 weeks then 800 IU/day oral vitamin D3 for 6 months + Dietary counseling
Arm Title
Treatment Arm # 3
Arm Type
Active Comparator
Arm Description
50,000 IU oral vitamin D2 per week x 12 weeks then 5,000 IU/day oral vitamin D3 for 6 months+ Dietary counseling
Arm Title
Treatment Arm # 4
Arm Type
Active Comparator
Arm Description
5,000 IU oral daily vitamin D3 for 9 months + Dietary counseling
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D (ergocalciferol and/ or cholecalciferol)
Intervention Description
To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.
Primary Outcome Measure Information:
Title
Vitamin D levels after completion of repletion dosing
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Vitamin D levels on maintenance dosing
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Medication compliance among participants
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Crohn's disease or Ulcerative colitis
In clinical remission or with mild disease activity as determined by the Harvey Bradshaw Index (CD) ≤7 or Ulcerative Colitis disease activity index ≤6.
25(OH)D level <30 ng/ml within three months of study enrollment
Provided verbal consent
18 years of age or older
Exclusion Criteria:
Unwilling to provide consent or lack capacity
Moderate to severe disease activity (Harvey Bradshaw index >7 or UCDAI >6)
Current pregnancy or attempting to conceive
Known coexisting hyperparathyroidism
Already on vitamin D supplementation, calcium supplementation or a multivitamin
BMI >30 kg/m²
History of kidney stones
Subjects <18 years of age - pediatric population with different recommended dosing than adults (10).
Non-english speakers
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
Citations:
PubMed Identifier
17653185
Citation
Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
Results Reference
background
PubMed Identifier
25732745
Citation
Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015 Apr;12(4):205-17. doi: 10.1038/nrgastro.2015.34. Epub 2015 Mar 3.
Results Reference
background
PubMed Identifier
22085500
Citation
Cantorna MT. Vitamin D, multiple sclerosis and inflammatory bowel disease. Arch Biochem Biophys. 2012 Jul 1;523(1):103-6. doi: 10.1016/j.abb.2011.11.001. Epub 2011 Nov 10.
Results Reference
background
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Vitamin D Repletion and Maintenance in IBD: How Much and How Often
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