The Prospective Improved Vitamin D Study for IBD Patients Part 2 (The PIVD Study Part 2)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Medication Adherence
研究概览
简要总结
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:
- What proportion of IBD patients adhere to Vitamin D supplement recommendations over a 12-month period?
- Is the ASK-12 Questionnaire valid in measuring adherence among IBD patients?
- Does the severity of a patient's Crohn's disease effect overall adherence, over a 12-month period?
- Does the severity of a patient's Ulcerative Colitis disease effect overall adherence, over a 12-month period?
- Does Vitamin D supplementation affect the health-related Quality of Life for IBD patients?
- 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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Those with a history of Vitamin D or calcium supplementation within 6 months prior to the trial.
- •Those who were seen once by the gastroenterology team but never followed up (no ongoing IBD care).
研究组 & 干预措施
Vitamin D
Participants who have IBD (UC or CD) will receive Vitamin D3 and will take a 2000 IU pill daily for 12 months.
干预措施: Vitamin D3 (Cholecalciferol) (Dietary Supplement)
结局指标
主要结局
Medication Adherence
时间窗: Enrollment to 12 month follow up
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.
次要结局
- Validity of ASK-12 Survey(Enrollment until 12 month follow up)
- Quality of Life Assessment(Enrollment until 12 month follow up)
- Crohn's Disease - Disease Severity(Enrollment until 12 -month follow up)
- Ulcerative Colitis - Disease Severity(Enrollment until 12-month follow up)
- Impact on Serum Vitamin D Levels(Enrollment until 12 month follow up)
研究者
Terry Ponich
Gastroenterology Team Clinician - Victoria Hospital (LHSC)
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's