Clinical trial NCT02579902: Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome
Official title: Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
inflammation
oxidative stress
clinical signs
vitamin D3
Lead sponsor: Ahvaz Jundishapur University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
timeFrame: up to six months
measure: Symptom Severity Score
timeFrame: up to six months
Secondary outcomes:
measure: Dietary intake
timeFrame: up to six months
measure: Body Weight
timeFrame: up to six months
measure: Body Mass Index (BMI)
timeFrame: up to six months
measure: Waist Circumference (WC)
timeFrame: up to six months
measure: Hip Circumference (HC)
timeFrame: up to six months
measure: Waist to Hip Ratio (WHR)
timeFrame: up to six months
measure: Blood Pressure (BP)
timeFrame: up to six months
measure: Health-related Quality of Life
timeFrame: up to six months
measure: Tumor Necrosis Factor-α (TNF-α)
timeFrame: up to six months
measure: Interleukin-10 (IL-10)
timeFrame: up to six months
measure: Interleukin-17 (IL-17)
timeFrame: up to six months
measure: Malondialdehyde (MDA)
timeFrame: up to six months
measure: Total Antioxidant Capacity (TAC)
timeFrame: up to six months
measure: 25-hydroxy vitamin D (25(OH)D)
timeFrame: up to six months
measure: Calcium
timeFrame: up to six months
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Ahvaz Jundishapur University of Medical Sciences
state: Khuzestan
Study officials:
References: