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Vitamin D Repletion and Maintenance in IBD: How Much and How Often

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ClinicalTrials.gov Identifier: NCT03053414
Recruitment Status : Withdrawn (change in study design before recruitment began)
First Posted : February 15, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eric Vasiliauskas, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Vitamin D Deficiency Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Vitamin D Dosing Strategy for Adequate Repletion and Maintenance in IBD Patients With Minimal Disease Activity
Estimated Study Start Date : February 20, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Treatment Arm # 1
50,000 IU oral vitamin D2 per week for 12 weeks + Dietary counseling
Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)
To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.

Active Comparator: Treatment Arm # 2
50,000 IU oral vitamin D2 per week x 12 weeks then 800 IU/day oral vitamin D3 for 6 months + Dietary counseling
Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)
To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.

Active Comparator: Treatment Arm # 3
50,000 IU oral vitamin D2 per week x 12 weeks then 5,000 IU/day oral vitamin D3 for 6 months+ Dietary counseling
Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)
To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.

Active Comparator: Treatment Arm # 4
5,000 IU oral daily vitamin D3 for 9 months + Dietary counseling
Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)
To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.




Primary Outcome Measures :
  1. Vitamin D levels after completion of repletion dosing [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Vitamin D levels on maintenance dosing [ Time Frame: 9 months ]

Other Outcome Measures:
  1. Medication compliance among participants [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Crohn's disease or Ulcerative colitis
  2. In clinical remission or with mild disease activity as determined by the Harvey Bradshaw Index (CD) ≤7 or Ulcerative Colitis disease activity index ≤6.
  3. 25(OH)D level <30 ng/ml within three months of study enrollment
  4. Provided verbal consent
  5. 18 years of age or older

Exclusion Criteria:

  1. Unwilling to provide consent or lack capacity
  2. Moderate to severe disease activity (Harvey Bradshaw index >7 or UCDAI >6)
  3. Current pregnancy or attempting to conceive
  4. Known coexisting hyperparathyroidism
  5. Already on vitamin D supplementation, calcium supplementation or a multivitamin
  6. BMI >30 kg/m²
  7. History of kidney stones
  8. Subjects <18 years of age - pediatric population with different recommended dosing than adults (10).
  9. Non-english speakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053414


Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center

Publications:
Responsible Party: Eric Vasiliauskas, Associate Clinical Director, Inflammatory Bowel Disease Program, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03053414     History of Changes
Other Study ID Numbers: Pro00045446
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamins
Vitamin D
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents