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Vitamin D Supplementation in IBS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148288
Recruitment Status : Terminated (low enrollment)
First Posted : May 10, 2017
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Vitamin D Deficiency Abdominal Pain Dietary Supplement: Vitamin D Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D supplementation
4000IU Vitamin D qd
Dietary Supplement: Vitamin D
VItamin D

Placebo Comparator: placebo Dietary Supplement: placebo
placebo




Primary Outcome Measures :
  1. Irritable Bowel Syndrome - Symptom Severity Scale (IBS-SSS) [ Time Frame: 12 weeks ]
    VAS on abdominal symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 enrollment).
  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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03148288    
Other Study ID Numbers: 2017P000133
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Vitamin D Deficiency
Abdominal Pain
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents