The Prospective Improved Vitamin D Study for Inflammatory Bowel Disease Patients (PIVD)

Terry Ponich

Status and phase: Not yet enrolling; Phase 1

Conditions: IBD (Inflammatory Bowel Disease); Ulcerative Colitis (UC); Crohn Disease (CD)

Treatments: Dietary Supplement: Vitamin D3 (Cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT07177157

WREM: 125544

Details and patient eligibility

About

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

Full description

Upon investigating the literature, despite there being a lot of medication compliance research, there was not much research catered to IBD patient medication management specifically.

Vitamin D supplementation based on immune-modulatory effects alongside its beneficial effects on bone health can lead to reduced rates of osteopenia and osteoporosis in the IBD population. In the treatment of IBD, the major patient care objectives to relieve symptoms and reduce inflammation doesn't leave much time or consideration for other aspects of patient care such as Vitamin D supplementation.

This study will investigate the gastroenterology department at LHSC to assess the current state of adherence and monitoring of Vitamin D and other medications for both Crohn's disease and ulcerative colitis patients. This will be done through a prospective cohort study of patients whose records have stated that they are not currently on Vitamin D. Through assessing overall adherence, foundational understanding of the IBD population will be obtained and the use the ASK-12 questionnaire will be validated. Once done, this would allow for a broader understanding of the patient specific factors affecting individual adherence and lay the foundation for research into ways at increasing adherence among non-adherent individuals.

The overall objective of this study is to estimate the proportion of patients that adhere to Vitamin D supplements. It is the hope that through investigations Vitamin D monitoring and adherence can be standardized at LHSC and long term osteoporosis and osteopenia complications commonly experienced by the IBD patient population can be prevented.

The central hypothesis is that Vitamin D adherence among IBD patients is low and that it is closely related to the patient's IBD disease severity. It is anticipated for this Vitamin D trend to be reversed, as patients may want to stabilize the disease condition and limit acute exacerbations prior to restarting maintenance therapy in the form of Vitamin D treatment.

A clinician as part of the gastroenterology team at Victoria Hospital or St. Joseph's Hospital (Dr. Ponich and other members of VH GI team) who is the primary healthcare contact for the recruited patient will make initial contact with potential participants. Dr. Ponich or another member of the VH GI team will approach the patient in clinic after their visit and ask a member of the research team to discuss the purpose and procedure of the study. The research team member will have the patients fill out a short-written consent form that meets the standards at LHSCRI as submitted in the WREM application. The research team member will obtain written consent from the patient.

Recruited patient's will be provided Vitamin D supplementation and be asked to take 2,000 IU/day. No additional reinforcement will be provided to these patients. At both 6- and 12-month intervals, remaining supplements will be collected, and overall adherence will be assessed. Participants will be asked to complete the EQ-5D-5L to assess their health-related quality of life and the ASK-12 Questionnaire, which will be compared to the pill counts, to determine the validity of ASK-12 among IBD patients. The Patients' IBD will be assessed by performing either a Partial Mayo or CDAI Score as well as completing a fecal calprotectin test. Additionally, participant serum Vitamin D levels will be collected to determine whether adherence to medication resulted in an identifiable increase.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults Aged 18-85
2. Diagnosis of IBD (Ulcerative Colitis or Crohn's Disease) within the patient's records based on standard clinical, endoscopic, and radiologic criteria.
3. 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).
4. Participants must have the ability to read, comprehend, and voluntarily provide informed consent without assistance.

Exclusion criteria

1. Those who do not meet the inclusion criteria.
2. 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).
3. 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).
4. Those using oral corticosteroids for the management of any disease other than IBD.
5. Those with a history of Vitamin D or calcium supplementation within 6 months prior to the trial.
6. Those who were seen once by the gastroenterology team but never followed up (no ongoing IBD care).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

Vitamin D

Experimental group

Description:

Participants who have IBD (UC or CD) will receive Vitamin D3 and will take a 2000 IU pill daily for 12 months.

Treatment:

Dietary Supplement: Vitamin D3 (Cholecalciferol)