EUCTR2010-019252-41-AT进行中（未招募）不适用
DALI dosing study of Vitamin D in obese pregnant women - DALI
VU University Medical Center0 个研究点目标入组 60 人开始时间: 2011年7月19日最近更新:
适应症
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
- 60
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 < 12 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 60
- •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
- •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
- •known current or past abnormal calcium metabolism (hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria)
- •hypercalciuria detected at screening (>0.6 mmol/mmol creatinine in spot morning urine) hypercalcaemia detected at screening (>10.6 mg/dl |2.65 mmol/l)
研究者
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