Irritable bowel syndrome Digestive System Irritable bowel syndrome
Conditions
Interventions
Patients administered 3000 IU (75 microg) vitamin D sublingual spray or placebo sublingual spray once daily for 12 weeks
Sponsors
The University of Sheffield
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Serum vitamin D concentrations will be assessed at baseline and exit: bloodspots will be taken and analysed by liquid chromatography-mass spectrometry . 2. Quality of life is assessed at baseline and exit using The Irritable Bowel Syndrome - Quality of Life questionnaire (IBS-QOL) | — |
Countries
United Kingdom
Contacts
Public ContactClaire Williams
Outcome results
None listed