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Ileostomy Observation Study

Assessment of Bone Mineral Density, Vitamin D Status and Calcium Intakes in Ileostomy Patients.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04143139
Enrollment
200
Registered
2019-10-29
Start date
2017-07-10
Completion date
2020-10-01
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy - Stoma

Keywords

Bone mineral density, Ileostomists, Vitamin D, Observational study, Calcium, Phytochemical

Brief summary

Inflammatory bowel disease (IBD) which is associated with low bone mineral density is divided into 2 major disease entities: Crohn's disease and ulcerative colitis. Medical therapy is directed at controlling symptoms and reducing the underlying inflammatory process. Studies have reported that 60% of patients with Crohn's disease and 15%-30% of patients with ulcerative colitis require surgical intervention for the management of their disease. In the United Kingdom almost 13,000 ileostomy procedures are undertaken annually. A 29.4% prevalence of low bone mineral density (BMD) was reported in a cohort of US patients with IBD and ileostomy who were \>5 years postoperative. Possible risk factors for bone loss in patients with IBD and ileostomy are considered to include malabsorption secondary to bowel resection, malnutrition and more aggressive disease and inflammation which led to bowel resection in the first place . These factors also contribute to reduced intestinal absorption of nutrients and vitamins including B & D subsequently leading to potential health complications including low BMI and low lean body mass. It has been reported that IBD patients who have surgical intervention to create ileal pouches also have low levels of vitamin D. Surgical procedures such as an ileostomy alter the normal anatomy and physiology of the small intestine. Bile acid (BA) malabsorption which is common to IBD is caused by impaired conjugated BA reabsorption and a consequence, numerous pathological sequelae may occur, including the malfunction of lipid digestion . Further, bacterial overgrowth can lead to deconjugation of bile salts, leading to formation of free bile acids, again inducing dietary fat malabsorption, which in turn can lead to vitamin D deficiency. As vitamin D is a fat-soluble vitamin, malfunction of lipid digestion or absorption is problematic. Given the paucity of data in the area of ileostomy patients BMD, vitamin D status and calcium intake, we will establish baseline observations within the Northern Ireland (NI) population with an observational study to assess bone mineral density (Dexa), collecting ileal fluid and plasma samples assessing vitamin D status, calcium, dietary intake and other measures including questionnaires on quality of life and exercise.

Interventions

None listed

Sponsors

University of Naples
CollaboratorOTHER
University of Ulster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* undergone an ileostomy and be more than 2 year post-operative * non smoking

Exclusion criteria

* not undergone an ileostomy and/or is less than 2 year post-operative * smoker.

Design outcomes

Primary

MeasureTime frameDescription
Bone Density1 day, 1 measurementDual Energy X-ray Absorptiometry (DXA)

Secondary

MeasureTime frameDescription
Parathyroid hormone concentrations commercial kit)1 day, 1 measurementCommercial kit
Serum adjusted calcium1 day, 1 measurementCommercial kit
Lipid profile1 day, 1 measurementCommercial kit
Plasma glucose1 day, 1 measurementCommercial kit
Dietary intake,1 day, 1 measurementFood dairy and Vitamin D Food Frequency Questionaire
Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit)1 day, 1 measurementLiquid Chromatography / Mass Spec (LC/MS)
Quality of life (QoL) questionnaire1 day, 1 measurementColoplast Stoma-QoL; 20 questions, 4-point scale. Higher value representing higher QoL
Heath and well being questionnaire1 day, 1 measurementSF36v2, Higher value representing a greater health and well-being status.
Recent Physical Activity Questionnaire (RPAQ)1 day, 1 measurementValidated questionnaire measuring time spent in active and sedentary behaviour.
Dietary component (plasma and ileal fluid) concentrations such as polyunsaturated fatty acids, endocannabinoids1 day, 1 measurementGas Chromatography Mass Spect (GCMS) and Liquid Chromatography / Mass Spec
Phytochemical concentrations (plasma and ileal fluid) analysis1 day, 1 measurementGas Chromatography Mass Spect (GCMS) and Liquid Chromatography / Mass Spec (LC/MS) Mass Spec (LC/MS)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026