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Vitamin D Supplementation in IBS

Primary Purpose

Irritable Bowel Syndrome, Vitamin D Deficiency, Abdominal Pain

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin D

placebo

About this trial

This is an interventional other trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
Be ambulatory, community dwelling, 18 to 80 years, inclusive
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.

Exclusion Criteria:

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 Vit D

Sites / Locations

Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D supplementation

placebo

Arm Description

4000IU Vitamin D qd

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome - Symptom Severity Scale (IBS-SSS)

VAS on abdominal symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT03148288

First Posted

May 9, 2017

Last Updated

May 4, 2020

Sponsor

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03148288

Brief Title

Vitamin D Supplementation in IBS

Official Title

Vitamin D Supplementation in IBS

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

low enrollment

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

March 20, 2018 (Actual)

Study Completion Date

March 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Vitamin D Deficiency, Abdominal Pain

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D supplementation

Arm Type

Experimental

Arm Description

4000IU Vitamin D qd

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Intervention Description

VItamin D

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Irritable Bowel Syndrome - Symptom Severity Scale (IBS-SSS)

Description

VAS on abdominal symptoms

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments. Be ambulatory, community dwelling, 18 to 80 years, inclusive 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. Exclusion Criteria: 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 Vit D

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Vitamin D Supplementation in IBS

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