Vitamin D Supplementation in IBS
NCT03148288 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2020-05-06
Summary
Irritable bowel syndrome (IBS) is a very common functional gastrointestinal disorder affecting nearly 20% of the North American population. IBS is characterized by chronic abdominal, associated with a change in bowel frequency and or consistency that lack a known structural or anatomic explanation. Current treatment for IBS is primarily symptom-based. However over a third of patients with IBS fail to respond to currently available therapies.
The prevalence of vitamin D deficiency/insufficiency is estimated in over a billion people world-wide . Vitamin D has potential mechanisms not only in the balance of calcium and bone homeostasis, but also a key modulator of the immune system. Vitamin D receptors (VDRs) are located on all nucleated cells including the GI tract. Thus far, there is already accumulating evidence for a role for vitamin D supplementation in inflammatory bowel disease (IBD). A recent systematic review suggested there may be benefits of vitamin D supplementation in IBD.
Vitamin D insufficiency is widespread in patients with IBS and there is a positive association between vitamin D status and quality of life. To date, there is no US trial examining the effect of vitamin d supplementation on IBS symptoms and quality of life in patients with IBS.
Conditions
- Irritable Bowel Syndrome
- Vitamin D Deficiency
- Abdominal Pain
Interventions
- DIETARY_SUPPLEMENT
-
Vitamin D
VItamin D
- DIETARY_SUPPLEMENT
-
placebo
placebo
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-01
- Primary Completion
- 2018-03-20
- Completion
- 2018-03-20
Countries
- United States
Study Locations
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