Vitamin D Supplementation in IBS
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|ClinicalTrials.gov Identifier: NCT03148288|
Recruitment Status : Terminated (low enrollment)
First Posted : May 10, 2017
Last Update Posted : May 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Vitamin D Deficiency Abdominal Pain||Dietary Supplement: Vitamin D Dietary Supplement: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Vitamin D Supplementation in IBS|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||March 20, 2018|
|Actual Study Completion Date :||March 20, 2018|
Experimental: Vitamin D supplementation
4000IU Vitamin D qd
Dietary Supplement: Vitamin D
|Placebo Comparator: placebo||
Dietary Supplement: placebo
- Irritable Bowel Syndrome - Symptom Severity Scale (IBS-SSS) [ Time Frame: 12 weeks ]VAS on abdominal symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148288
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|