EUCTR2013-000789-13-AT进行中（未招募）不适用
Vitamin D And Lifestyle Intervention for Gestational Diabetes Mellitus (GDM) Prevention - A European multicentre, randomised trial: Vitamin D limb. - DALI
VU University Medical Center0 个研究点目标入组 440 人开始时间: 2013年6月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
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
- Female
入选标准
- •pre-pregnancy BMI (self-reported weight, measured height) is = 29 kg/m2)
- •aged 18 years or more
- •singleton pregnancy
- •gestational age at recruitment < 20 weeks
- •sufficiently fluent in major language of the country of recruitment
- •being able to be moderately physically active
- •giving written informed consent
- •agreeing to give birth in one of the participating hospitals
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 440
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •pre-existing diabetes
- •diagnosed with (gestational) diabetes mellitus before randomisation defined as fasting glucose = 5.1 mmol/l and/or 1 hour glucose = 10mmol/l and/or 2 hour glucose =8.5 mmol/l at baseline measurement.
- •not able to walk at least 100 meters safely
- •requirement for complex diets
- •advanced chronic conditions (e.g. valvular heart disease)
- •significant psychiatric disease
- •unable to speak major language of the country of recruitment fluently
研究者
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