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临床试验/EUCTR2013-003546-16-AT
EUCTR2013-003546-16-AT进行中(未招募)1 期

The Link between Obesity And Vitamin D in bariatric patients with omega-loop bypass surgery: a randomized controlled, double-blinded clinical supplementation trial - LOAD - LOAD

Medizinische Universität Wien, Klin. Abt. für Endokrinologie & Stoffwechsel, Universitätsklinik für Innere Medizin III0 个研究点开始时间: 2014年2月12日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Men and women over the age of 18 and under 100 years
  • Planned omega loop bypass surgery
  • 25-OHD < 75 nmol/l
  • BMI > 40 or = 35 kg/m2 with co-morbidities e.g. diabetes mellitus and hypertension
  • Body weight < 150 kg (due to limitation of DEXA measurement)
  • Capability to consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 50

排除标准

  • Another planned form of bariatric surgery
  • Hypercalcemia (calcium > 2.63 mmol/l) or hypocalcemia (calcium < 1.75 mmol/l)
  • Renal insufficiency (creatinine > 133 µmol/l or GFR < 50 ml/min)
  • Primary hyperparathyroidism
  • infection e.g. human immunodeficiency virus
  • Medical conditions requiring daily calcium
  • supplements or antacid use
  • Known hypersensitivity to cholecalciferol
  • No capability to consent
  • Imprisoned persons

研究者

发起方
Medizinische Universität Wien, Klin. Abt. für Endokrinologie & Stoffwechsel, Universitätsklinik für Innere Medizin III

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