---
title: Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome
nct_id: NCT02579902
overall_status: COMPLETED
phase: PHASE1
sponsor: Ahvaz Jundishapur University of Medical Sciences
study_type: INTERVENTIONAL
primary_condition: Irritable Bowel Syndrome
countries: Iran
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02579902.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02579902"
ct_last_update_post_date: 2015-11-30
last_seen_at: "2026-05-12T07:10:47.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02579902](https://clinicaltrials.gov/study/NCT02579902)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Ahvaz Jundishapur University of Medical Sciences
- **Conditions:** Irritable Bowel Syndrome
- **Start Date:** 2015-02
- **Completion Date:** 2015-09
- **CT.gov Last Update:** 2015-11-30

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Vitamin D3** (ACTIVE_COMPARATOR) — 50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.
- **placebo** (PLACEBO_COMPARATOR) — Placebo capsule, one capsule every 2 weeks for 6 months.

## Interventions

- **Vitamin D3 (Cholecalciferol)** (DIETARY_SUPPLEMENT) — 50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.
- **placebo** (DIETARY_SUPPLEMENT) — placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.

## Primary Outcomes

- **Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency** _(time frame: up to six months)_ — clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.
- **Symptom Severity Score** _(time frame: up to six months)_ — symptom severity score will be assessed by IBS-Symptom Severity Score (IBS-SSS) self-report questionnaire baseline and after six months intervention.

## Secondary Outcomes

- **Dietary intake** _(time frame: up to six months)_
- **Body Weight** _(time frame: up to six months)_
- **Body Mass Index (BMI)** _(time frame: up to six months)_
- **Waist Circumference (WC)** _(time frame: up to six months)_
- **Hip Circumference (HC)** _(time frame: up to six months)_
- **Waist to Hip Ratio (WHR)** _(time frame: up to six months)_
- **Blood Pressure (BP)** _(time frame: up to six months)_
- **Health-related Quality of Life** _(time frame: up to six months)_
- **Tumor Necrosis Factor-α (TNF-α)** _(time frame: up to six months)_
- **Interleukin-10 (IL-10)** _(time frame: up to six months)_
- **Interleukin-17 (IL-17)** _(time frame: up to six months)_
- **Malondialdehyde (MDA)** _(time frame: up to six months)_
- **Total Antioxidant Capacity (TAC)** _(time frame: up to six months)_
- **25-hydroxy vitamin D (25(OH)D)** _(time frame: up to six months)_
- **Calcium** _(time frame: up to six months)_

## Locations (1)

- Ahvaz Jundishapur University of Medical Sciences, Ahvāz, Khuzestan, Iran

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ahvaz jundishapur university of medical sciences|ahvāz|khuzestan|iran` — added _(2026-05-12)_

---

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