Ileostomy Observation Study
Research type
Research Study
Full title
Assessment of bone mineral density, vitamin D status and calcium intakes in ileostomy patients
IRAS ID
207333
Contact name
Chris I R Gill
Contact email
Sponsor organisation
Ulster University
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Inflammatory bowel disease (IBD) which is associated with low bone mineral density (BMD) is divided into 2 major disease entities: Crohn's disease (CD) and ulcerative colitis (UC). Medical therapy is directed at controlling symptoms and reducing the underlying inflammatory process. Studies have reported that 60% of patients with CD and 15%–30% of patients with UC require surgical intervention for the management of their disease. In the UK almost 13,000 ileostomy procedures are undertaken annually. Researchers in the US recently highlighted low BMD in approximately one third of patients with IBD and ileostomy who were >5 years postoperative. It has also been reported that IBD patients who have surgical intervention to create ileal pouches also have low levels of vitamin D.
Given the lack of data in the area of ileostomy patients, the aim of this observational study is to investigate associations between BMD, vitamin D status and calcium intake within the NI population, and also to collect information on the body composition, health and well-being of ileostomy patients.
Two hundred patients who have previously had an ileostomy will be recruited and asked to attend an appointment where they will complete a Health & Well-being Questionnaire and a Quality of Life (QoL) Questionnaire. Ileal fluid from their overnight stoma bag will be collected, as will one 20ml blood sample. They will also be given instructions on completing a 4-day food diary. No more than 3 weeks later, patients will be asked to return for a second appointment where a Dual Energy X-ray Absorptiometry (DXA) scan will be performed to assess BMD and body composition. Patients height and weight will be measured, and a vitamin D food frequency questionnaire (FFQ) and physical activity questionnaire will be completed.
REC name
HSC REC A
REC reference
16/NI/0267
Date of REC Opinion
18 Jan 2017
REC opinion
Further Information Favourable Opinion