跳至主要内容
临床试验/NCT04143139
NCT04143139Unknown不适用

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

University of Ulster1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年7月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Bone Density

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • not undergone an ileostomy and/or is less than 2 year post-operative

结局指标

主要结局

Bone Density

时间窗: 1 day, 1 measurement

Dual Energy X-ray Absorptiometry (DXA)

次要结局

  • Dietary intake,(1 day, 1 measurement)
  • Phytochemical concentrations (plasma and ileal fluid) analysis(1 day, 1 measurement)
  • Quality of life (QoL) questionnaire(1 day, 1 measurement)
  • Heath and well being questionnaire(1 day, 1 measurement)
  • Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit)(1 day, 1 measurement)
  • Lipid profile(1 day, 1 measurement)
  • Parathyroid hormone concentrations commercial kit)(1 day, 1 measurement)
  • Serum adjusted calcium(1 day, 1 measurement)
  • Plasma glucose(1 day, 1 measurement)
  • Recent Physical Activity Questionnaire (RPAQ)(1 day, 1 measurement)
  • Dietary component (plasma and ileal fluid) concentrations such as polyunsaturated fatty acids, endocannabinoids(1 day, 1 measurement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验