Can vitamin D improve symptoms and quality of life in people with irritable bowel syndrome (IBS)?

Not Applicable

Completed

• Conditions: Irritable bowel syndrome; Digestive System

• Registration Number: ISRCTN13277340
• Lead Sponsor: The University of Sheffield

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34328539/ (added 02/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-25
• Study Completion: 2020-09-30
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Clinical diagnosis of IBS using the ROME criteria and reaching severity score of 150 on SSS scale at time of recruitment. As some participants may have active IBS but historic diagnosis, no one version of ROME is specified as long as a clinical diagnosis was made at the time.

Exclusion Criteria

1. Pregnant or lactating
2. Regular use of nutritional supplements
3. BMI >30 kg/m2
4. BMI <18 kg/m2
5. Any history of gastrointestinal disorders (Crohn’s disease, ulcerative colitis, diverticulitis)
6. Diabetes mellitus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Total Symptom Severity for IBS, measured by visual analogue scale (VAS) at baseline and exit, and a cumulative measure taken fortnightly across the intervention period (weeks 0, 2, 4, 6, 8, 10, 12).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Serum vitamin D concentrations will be assessed at baseline and exit: bloodspots will be taken and analysed by liquid chromatography-mass spectrometry .<br> 2. Quality of life is assessed at baseline and exit using The Irritable Bowel Syndrome - Quality of Life questionnaire (IBS-QOL)<br>