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临床试验/NCT04412421
NCT04412421Unknown不适用

Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery

Region Östergötland1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2017年5月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
260
试验地点
1
主要终点
Time to discontinuation

研究概览

简要总结

The aim of this study is to assess medication adherence to vitamin and mineral supplements after bariatric surgery and identify factors that may influence adherence. All study participants are prescribed life-long treatment with daily oral vitamin B12 and Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation. Post-operative adherence rate is retrieved from Pharmacy refill data, collected from the Swedish Prescribed Drug Register, the five first years after bariatric surgery.

详细描述

The aim of this study is to assess medication adherence to vitamin- and mineral supplementation after bariatric surgery, identify factors that may influence adherence, as well as study the development of micronutrient deficinencies detectable by blood sampling.

All study participants are prescribed life-long treatment with daily oral vitamin B12 and Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation.

Post-operative adherence rate is retrieved from pharmacy refill data, collected from The Swedish Prescribed Drug Register, at one, two and five years after bariatric surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Informed consent
  • Patients subjected to bariatric surgery at Vrinnevi Hospital, Norrköping, Sweden

排除标准

  • Unable to read and understand Swedish

结局指标

主要结局

Time to discontinuation

时间窗: 5 years

Discontinuation (Time to discontinuation)

Time to initiation

时间窗: 1 year

Initiation (time to initiation)

Adherence to vitamin and mineral supplementation

时间窗: 5 years

Implementation (Continuous multiple-interval measures of medication availability/gaps, CMA),

次要结局

  • p-calcium(5 years)
  • s-albumin(5 years)
  • s-cobolamin(5 years)
  • s-folate(5 years)
  • Self reported Adherence to vitamin-and mineral supplementation(5 years)
  • Hemoglobin (Hb)(5 years)
  • Iron status(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Andersson

MD, PhD, Consultant Upper GI Surgeon

Region Östergötland

研究点 (1)

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