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High Dose Vitamin D3 in Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Vitamin D

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a prior diagnosis of Crohn's disease in clinical remission for at least 28 days with a Harvey-Bradshaw index less than or equal to 4
  • All maintenance therapies for Crohn's disease will be required to be at stable dose for at least 3 months before randomization, with no systemic steroid therapy within 4 weeks.
  • Vitamin D supplements will be discontinued at least 6 weeks before randomization.

Exclusion Criteria:

  • Women of child bearing potential who are considering pregnancy during the study period, currently pregnant, or unwilling to use contraception to avoid pregnancy
  • Participants with renal insufficiency (serum creatinine greater than 150 umol/L), sarcoidosis, hyperparathyroidism, malignancy, or any other disorder that may lead to hypercalcemia
  • Patients with short-gut syndrome or a serum albumin less than 32 g/L
  • Concomitant therapy with thiazide diuretics, barbiturates, digitalis, or supplemental products containing vitamin D

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    High Dose Vitamin D3 (10,000 IU daily)

    Low Dose Vitamin D3 (1000 IU daily)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Improvement in 25-OH vitamin D level

    Secondary Outcome Measures

    Clinical Remission (defined as Harvey-Bradshaw index <=4)
    Number of patients who maintain clinical remission
    Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS))
    Number of patients who achieve significant improvement in HADS (reduction of 2 or more)
    Improvement in C-reactive protein
    Comparison of C-reactive protein levels in high and low dose vitamin D3 groups
    Adverse events
    Number of patients with treatment-related adverse events, including death, hypercalcemia, and hospitalization, as well as minor adverse events

    Full Information

    First Posted
    November 23, 2015
    Last Updated
    November 24, 2015
    Sponsor
    McMaster University
    Collaborators
    Canadian Association of Gastroenterology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02615288
    Brief Title
    High Dose Vitamin D3 in Crohn's Disease
    Official Title
    Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    Canadian Association of Gastroenterology

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000 International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's disease in remission.
    Detailed Description
    In patients with Crohn's disease in remission, the investigators hypothesized higher doses of vitamin D would more effectively improve 25-hydroxy(OH)-vitamin D levels and would be tolerated well without side effects of hypercalcemia. The investigators also wanted to explore whether higher doses could reduce the clinical relapse rate of patients with Crohn's disease in remission, and if higher doses of vitamin D3 could improve depression and anxiety symptoms. In order to determine if there is benefit from high-dose vitamin D3, the investigators designed a pilot randomized double-blind controlled trial comparing doses of oral vitamin D3 at 10,000 IU daily to 1000 IU daily.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease
    Keywords
    Vitamin D

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Dose Vitamin D3 (10,000 IU daily)
    Arm Type
    Active Comparator
    Arm Title
    Low Dose Vitamin D3 (1000 IU daily)
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D3
    Primary Outcome Measure Information:
    Title
    Improvement in 25-OH vitamin D level
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Clinical Remission (defined as Harvey-Bradshaw index <=4)
    Description
    Number of patients who maintain clinical remission
    Time Frame
    One year
    Title
    Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS))
    Description
    Number of patients who achieve significant improvement in HADS (reduction of 2 or more)
    Time Frame
    One year
    Title
    Improvement in C-reactive protein
    Description
    Comparison of C-reactive protein levels in high and low dose vitamin D3 groups
    Time Frame
    One year
    Title
    Adverse events
    Description
    Number of patients with treatment-related adverse events, including death, hypercalcemia, and hospitalization, as well as minor adverse events
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a prior diagnosis of Crohn's disease in clinical remission for at least 28 days with a Harvey-Bradshaw index less than or equal to 4 All maintenance therapies for Crohn's disease will be required to be at stable dose for at least 3 months before randomization, with no systemic steroid therapy within 4 weeks. Vitamin D supplements will be discontinued at least 6 weeks before randomization. Exclusion Criteria: Women of child bearing potential who are considering pregnancy during the study period, currently pregnant, or unwilling to use contraception to avoid pregnancy Participants with renal insufficiency (serum creatinine greater than 150 umol/L), sarcoidosis, hyperparathyroidism, malignancy, or any other disorder that may lead to hypercalcemia Patients with short-gut syndrome or a serum albumin less than 32 g/L Concomitant therapy with thiazide diuretics, barbiturates, digitalis, or supplemental products containing vitamin D

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27975236
    Citation
    Narula N, Cooray M, Anglin R, Muqtadir Z, Narula A, Marshall JK. Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn's Disease in Remission: A Pilot Randomized Double-Blind Controlled Study. Dig Dis Sci. 2017 Feb;62(2):448-455. doi: 10.1007/s10620-016-4396-7. Epub 2016 Dec 14.
    Results Reference
    derived

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    High Dose Vitamin D3 in Crohn's Disease

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