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The Prospective Improved Vitamin D Study for Inflammatory Bowel Disease Patients

ConditionsUlcerative Colitis (UC)IBD (Inflammatory Bowel Disease)Crohn Disease (CD)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTerry Ponich

About this trial

The aim of this clinical trial is to gain a better understanding of the effect of Vitamin D supplementation on disease activity and overall health. The main questions it aims to answer are:

1. What proportion of IBD patients adhere to Vitamin D supplement recommendations over a 12-month period? 2. Is the ASK-12 Questionnaire valid in measuring adherence among IBD patients? 3. Does the severity of a patient's Crohn's disease effect overall adherence, over a 12-month period? 4. Does the severity of a patient's Ulcerative Colitis disease effect overall adherence, over a 12-month period? 5. Does Vitamin D supplementation affect the health-related Quality of Life for IBD patients? 6. Is 2,000 IU/Day an effective dose to sustain appropriate blood Vitamin D levels among previously Vitamin deficient IBD patients?

Participants will:

* Take 2000 IU of Vitamin D every day for the next 12 months * Complete 2 surveys, bloodwork and a fecal calprotectin test at the initial, visit, 6 month follow up and 12 month follow up

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults Aged 18-85

Diagnosis of IBD (Ulcerative Colitis or Crohn's Disease) within the patient's records based on standard clinical, endoscopic, and radiologic criteria.

Patients within outpatient gastroenterology clinics at Victoria Hospital and St. Joseph's Hospital with follow-up appointments within the next 2 years (ongoing IBD care).

Participants must have the ability to read, comprehend, and voluntarily provide informed consent without assistance.

Disqualifiers

Those who do not meet the inclusion criteria.

Those with any concurrent diagnosis of disease that may affect calcium or Vitamin D metabolism (i.e., rheumatoid arthritis or other inflammatory joint disease, thyroid disease, parathyroid disease, primary bone disease, granulomatous disease, sarcoidosis, lymphoma).

Those with either renal dysfunction (serum creatinine >0.150 mmol/L) or receiving dialysis were excluded, patients with chronic liver disease, and hypercalcemia (>2.65mmol/L).

Those using oral corticosteroids for the management of any disease other than IBD.

Trial design

Design model

Single group

Treatments tested in this trial

  • Vitamin D3 (Cholecalciferol)

    Dietary supplement

    2000 IU of Vitamin D daily (1 pill)

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Vitamin DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Medication Adherence

Assessing the proportion of IBD patients, at both 6 and 12 months, who are adherent to Vitamin D supplementation using pill-counting of supplements provided to them.

Time frame
Enrollment to 12 month follow up

Secondary outcomes

1

Validity of ASK-12 Survey

Determining the validity of the ASK-12 survey, a 12-item Short Health Survey adherence tool will be used to assess adherence rates, among the IBD patients. The ASK-12 Questionnaire detects patient specific barriers to medication adherence, with scores ranging from 12-60 (higher scores indicating a greater non-adherence). The ASK-12 also contains 3 separate subscales: (1) Adherence Behaviors, (2) Health Beliefs, (3) Inconvenience/Forgetfulness.

Time frame
Enrollment until 12 month follow up
2

Quality of Life Assessment

Assessing the change in quality-of-life among IBD patient's using the EQ-5D-5L survey to assess the general health among the patient population. The EQ-5D-5L Health Survey is a 5- item survey that assesses both physical and mental health. There are 5 subcategories that consist of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. There is also a scale where the patient assesses their current overall health ranging from 0 (the worst health they can imagine) to 100 (the best health they can imagine). This tool will be used to compare any changes in health-related quality of life among IBD patients based on their individual rates to supplementations.

Time frame
Enrollment until 12 month follow up
3

Crohn's Disease - Disease Severity

Assessing the patient's Crohn's Disease severity using the Crohn's disease activity index (CDAI) respectively. The CDAI is a validated tool in assessing disease severity among Crohn's disease patients, with a score \>150 indicative of active disease. Any other scores would indicate that the disease is in remission. It will also be looked at by testing fecal calprotectin levels which will allow for comparison of the level of inflammation.

Time frame
Enrollment until 12 -month follow up
4

Ulcerative Colitis - Disease Severity

Assessing the patient's Ulcerative Colitis disease severity using the Mayo Disease Activity Index (DAI) respectively. The DAI is a validated tool used in assessing disease severity among Ulcerative Colitis patients, with a score \>2 indicative of active disease. Any other scores would indicate that the disease is in remission. It will also be looked at by testing fecal calprotectin levels which will allow for comparison of the level of inflammation.

Time frame
Enrollment until 12-month follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Terry Ponich

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: