NCT03148288

Vitamin D Supplementation in IBS

Terminated NA Last updated 6 May 2020

What this trial tests

NA trial testing Vitamin D in Irritable Bowel Syndrome in 7 participants. Terminated before completion.

Timeline

1 September 2017

Primary endpoint
20 March 2018

20 March 2018

Quick facts

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	other
Enrollment	7
Start date	1 September 2017
Primary completion	20 March 2018
Estimated completion	20 March 2018
Sites	1 location across United States

Drugs / interventions tested

• Vitamin D
• placebo

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
• Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
• Abdominal Pain — all drugs for Abdominal Pain →

Sponsor

Beth Israel Deaconess Medical Center

Who can join

Adults 18 to 80, any sex, with Irritable Bowel Syndrome or Vitamin D Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.