Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome
1 other identifier
interventional
90
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2015
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 11, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedNovember 30, 2015
November 1, 2015
6 months
October 11, 2015
November 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.
up to six months
Symptom Severity Score
symptom severity score will be assessed by IBS-Symptom Severity Score (IBS-SSS) self-report questionnaire baseline and after six months intervention.
up to six months
Secondary Outcomes (15)
Dietary intake
up to six months
Body Weight
up to six months
Body Mass Index (BMI)
up to six months
Waist Circumference (WC)
up to six months
Hip Circumference (HC)
up to six months
- +10 more secondary outcomes
Study Arms (2)
Vitamin D3
ACTIVE COMPARATOR50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.
placebo
PLACEBO COMPARATORPlacebo capsule, one capsule every 2 weeks for 6 months.
Interventions
50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.
placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.
Eligibility Criteria
You may qualify if:
- The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahvaz Jundishapur University of Medical Sciences
Ahvāz, Khuzestan, 15794 - 61357, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D candidate of Nutrition Sciences
Study Record Dates
First Submitted
October 11, 2015
First Posted
October 20, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
November 30, 2015
Record last verified: 2015-11