Vitamin D Supplementation in IBS

Conditions:Irritable Bowel Syndrome (IBS), Other Indications, Gastrointestinal, Pain
Therapuetic Areas:Gastroenterology, Musculoskeletal, Other
Age Range:18 - 80
Start Date:September 1, 2017
End Date:December 14, 2019
Contact:Vivian Cheng

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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.

Inclusion Criteria:

1. Provide signed and dated informed consent and understand the nature of the study
sufficiently to allow completion of all study assessments.

2. Be ambulatory, community dwelling, 18 to 80 years, inclusive

3. Meet Rome IV diagnostic criteria for IBS

4. Have IBS of at least "moderate" severity, i.e., have a score on the IBS-SSS of > 175
(0-500) at the baseline visit (Visit 1)

5. If the patient is on medications which affect the gastrointestinal tract or visceral
sensation (e.g., tricyclic antidepressants, fiber, antispasmodics, etc.) they must be
on a stable dose for at least 1 month prior to entering the study and for the duration
of the study.

Exclusion Criteria:

1. Have a history of intractable IBS, defined as continuous, unremitting and severe
abdominal pain.

2. Be pregnant or lactating.

3. Have an established diagnosis of any concomitant bowel disturbance that would
interfere with the assessment of efficacy or safety in the study (e.g., Hirschsprung's
disease, inflammatory bowel disease, celiac disease).

4. Report warning symptoms (i.e., rectal bleeding, weight loss >10%, iron deficiency
anemia, etc.) otherwise not explained

5. Have undergone previous abdominal surgery (with the exception of uncomplicated
appendectomy, cholecystectomy, hysterectomy, or polypectomy > 6 months prior to

6. Have a history of metabolic or inflammatory disease that may affect bowel motility
(e.g., inflammatory bowel disease, celiac, sarcoidosis, connective tissue disease,
amyloidosis, or poorly controlled hypo/hyperthyroidism).

7. Have a history of significant concomitant psychiatric, neurological, metabolic,
hepatic, renal, infectious, hematological, cardiovascular, gastrointestinal, or
pulmonary illness. If there is a history of such disease but the condition has been
stable for more than one year and is judged by the Investigator not to interfere with
the patient's participation in the study, the patient may be included. Staff will
document such cases.

8. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2
years of entry into the study

9. Exhibit abnormalities on physical examination, have abnormal vital signs, or clinical
laboratory values, unless these abnormalities are judged to be clinically
insignificant by the Investigator. Such cases will be noted.

10. Active laxative abuse.

11. Unable or unwilling to cooperate with the study protocol or considered by the
Investigator to be unsuitable for the study.

12. Currently taking Vitamin D supplements

13. Diagnosis of osteoporosis

14. Currently bisphosphonate medications

15. Those who taking medication known to interfere with Vit D
We found this trial at
330 Brookline Ave
Boston, Massachusetts 02215
Phone: 617-667-0682
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Boston, MA
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