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

Plain English summary of protocol

Background and study aims
Irritable bowel syndrome (IBS) is a common condition that affects the digestive system. IBS is usually experienced for a life-time and symptoms include bloating, constipation, diarrhoea, and stomach cramps. These symptoms can affect a person for days, weeks or even months at a time. This can be a difficult condition to live with and can have a large impact on a person's everyday life. The cause of IBS is unknown, although it is thought to be associated with a family history of IBS, stress and certain foods. IBS cannot be cured but can often be managed with medication and dietary changes. Research has shown that people with IBS also have low levels of vitamin D. The aim of this study is to assess whether increasing vitamin D levels in people with IBS helps to improve their symptoms.

Who can participate?
Men and women aged between 18-60 years with a diagnosis of IBS

What does the study involve?
Each person will be put into one of two groups to receive either a vitamin D or placebo (dummy) supplement mouth spray to be taken each day for 12 weeks. All participants will be asked to fill in a total of seven Symptom Severity Questionnaires (SSS-IBS), two Quality of Life Questionnaires (QoL), and one Food Frequency Questionnaire (FFQ). All participants will have blood samples taken at the first and last appointment. This will be done with a finger prick blood test kit. All participants will take a mouth spray, only half of the volunteers will get the active (real) vitamin D supplement.

What are the possible benefits and risks of participating?
The supplement that participants will be taking are well under the advised limit, however, there is a very unlikely risk of vitamin D levels going too high. Side effects of excessive vitamin D levels include raised calcium blood levels, nausea and constipation. Participants will be monitored closely for any problems they may experience during the study. There will also be small risks involved with taking blood samples, such as pain around the site of
insertion, as with any blood test. These risks will be clearly explained to the participants. The finger prick only occurs twice; at the start and end of the 12 weeks. Volunteers on the active (real) supplement may benefit from their participation in the research as they may see an improvement in their symptoms and all volunteers will receive a £50.00 voucher as a thank you for their participation.

Where is the study run from?
This study will be run from the Medical School at the University of Sheffield.

When is the study starting and how long is it expected to run for?
Recruitment will occur three times over the next 2 years. The first two rounds will occur in the winter periods (Jan-Apr) in 2018 and 2019 in the local area with the goal of reaching 160 volunteers. A further recruitment will take place in 2019 to recruit volunteers from outside the local area and will use postal and online methods to complete the research. The anticipated start date of the trial is September 2018 and will run until September 2020.

Who is funding the study?
This research has been part funded by the University of Sheffield and by an industry partner BetterYou.

Who is the main contact?
The main person to contact regarding this study is Dr Bernard Corfe, Senior Lecturer in Oncology Principal Investigator in Molecular Gastroenterology, Fellow of Insigneo, b.m.corfe@sheffield.ac.uk.

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centre

Results and Publications

Study outputs

Editorial Notes

02/08/2021: Publication reference and total final enrolment added.