The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery: a Randomized Controlled, Double-blinded Clinical Supplementation Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 25-hydroxy vitamin D levels
研究概览
简要总结
The aim of the study is to increase vitamin D concentrations or to keep it on high level, respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the overall health status in bariatric patients. In this project, the vitamin D status, the parameters of inflammation, bone turnover, insulin resistance, liver and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned omega loop bypass surgery
- •25-hydroxy vitamin D < 75 nmol/l
- •BMI >40 or ≥35 kg/m2 with co-morbidities e.g. diabetes mellitus, hypertension
- •Body weight <140 kg (due to limitation of DEXA measurement)
- •Capability to consent
排除标准
- •Another planned form of bariatric surgery
- •Hypercalcemia (calcium >2.63 mmol/l) or hypocalcemia (<1.75 mmol/l)
- •Renal insufficiency (creatinine >133 μmol/l or GFR <50 ml/min)
- •Primary hyperparathyroidism
- •Malignancy
- •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
研究组 & 干预措施
Intervention
The loading dose of 300 000 IU is divided into three doses (100 000 IU) and will be given over the first months. All patients in the intervention group will receive the first loading dose of 100 000 IU at day of discharge. The second (2 weeks) and third (4 weeks postoperative) administration will be given based on the 25-hydroxy vitamin D concentration. After the last respectively third loading dose a maintenance dose of 3420 IU per day should maintain the high 25-hydroxy vitamin D concentration. It should be administered for up to 46 weeks (until follow-up visit)
干预措施: Cholecalciferol (Drug)
Placebo
The placebo loading dose (oil) is divided into three administrations and will be given over the first months. All patients in the placebo group will receive the first placebo loading dose at day of discharge. After the last placebo loading dose a maintenance dose of 3420 IU per day should maintain the 25-hydroxy vitamin D concentration. It should be administered for up to 46 weeks (until follow-up).
干预措施: Placebo (Drug)
结局指标
主要结局
25-hydroxy vitamin D levels
时间窗: 24 weeks postoperatively
25-hydroxy vitamin D levels after 24 weeks measured in intervention and placebo group, adjusting for the baseline value as covariate
次要结局
- Co-morbidities(24 weeks postoperatively)
- Laboratory parameters(24 weeks postoperatively)
- Prevalence of vitamin D deficiency(24 weeks postoperatively)
- Prevalence of sufficient vitamin D(24 weeks postoperatively)
- Blood pressure(24 weeks postoperatively)
- Depression symptoms(24 weeks postoperatively)
- Prescribed medication(24 weeks postoperatively)
- Body weight, body composition(24 weeks postoperatively)
- Bone mineral density and body fat content(24 weeks postoperatively)
- Liver condition(24 weeks postoperatively)
- Dietary assessment(24 weeks postoperatively)
- Gut microbiota composition(24 weeks postoperatively)
- Vitamin D in adipose and liver tissue(during surgery)
研究者
Maria Luger
Maria Luger, MSc
Medical University of Vienna