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Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

NCT ID: NCT02579902

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to determine whether vitamin D3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to Irritable Bowel Syndrome (IBS).

Detailed Description

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This randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) diagnosed with IBS. The intervention group will receive 50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once every 2 weeks for six months. Variables including biomarkers of inflammation and oxidative stress, serum levels of calcium and vitamin D, anthropometric indicators and blood pressure will be measured at baseline and end of the study. The investigators will use Rome III questionnaire for evaluating the clinical signs of the disease. The questionnaires will be filled out at baseline and every 2 weeks by the patients for six months.

Conditions

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Irritable Bowel Syndrome

Keywords

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Irritable Bowel Syndrome inflammation oxidative stress clinical signs vitamin D3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3

50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.

Group Type ACTIVE_COMPARATOR

Vitamin D3 (Cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.

placebo

Placebo capsule, one capsule every 2 weeks for 6 months.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.

Interventions

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Vitamin D3 (Cholecalciferol)

50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.

Exclusion Criteria

* Patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests)
* Any other diseases of the gastrointestinal tract such as Inflammatory Bowel Disease (IBD)
* Any kind of abdominal surgery
* Chronic disease such as diabetes
* Cardiovascular, hepatic
* Kidney and severe infection
* Pregnancy
* Breastfeeding
* Smoking
* Alcohol consumption
* Use of dietary supplements
* Use of vitamin D and calcium supplement during the last year before the study
* Use any medication for signs improvement during the study period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahvaz Jundishapur University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir Abbasnezhad

Ph.D candidate of Nutrition Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahvaz Jundishapur University of Medical Sciences

Ahvāz, Khuzestan, Iran

Site Status

Countries

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Iran

Other Identifiers

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ir.ajums.rec.1394.306

Identifier Type: -

Identifier Source: org_study_id