This trial investigates the effect of supplementing with Vitamin D on irritable bowel syndrome (IBS) symptoms for people with the condition. The investigators are interested in this because over ⅓ of patients do not respond to available treatments of symptoms and Vitamin D may provide benefits for inflammatory bowel disease (IBD) and IBS.
Investigators are looking for 90 participants for this study who will be randomly split into two groups. The first group will receive 4000IU Vitamin D and the other will receive a placebo.
- Provide signed and dated informed consent
- Ages 18-80
- Must be ambulatory and community dwelling
- Meet Rome IV diagnostic criteria for IBS
- 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)
- 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.
- Have a history of intractable IBS, defined as continuous, unremitting and severe abdominal pain.
- Be pregnant or lactating.
- 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).
- Report warning symptoms (i.e., rectal bleeding, weight loss >10%, iron deficiency anemia, etc.) otherwise not explained
- Have undergone previous abdominal surgery (with the exception of uncomplicated appendectomy, cholecystectomy, hysterectomy, or polypectomy > 6 months prior to enrollment).
- 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).
- 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.
- Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study
- 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.
- Active laxative abuse.
- Unable or unwilling to cooperate with the study protocol or considered by the Investigator to be unsuitable for the study.
- Currently taking Vitamin D supplements
- Diagnosis of osteoporosis
- Currently bisphosphonate medications
- Those who taking medication known to interfere with Vitamin D
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Contact: Vivian Cheng, MS, MPH 617-667-0682 firstname.lastname@example.org
Beth Israel Deaconess Medical Center
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