NL-OMON36181撤回2 期
DALI: Vitamin D and Lifestyle Intervention for GDM Prevention: dosing study - DALI
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •* able to be oderately physically active
- •* gives written informed consent
- •* Agree to give birth in one of the participating hospitals
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 * 10 mmol/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
- •* 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
相似试验
进行中（未招募）
1 期
DALI: finding the right intervention for the prevention of gestational diabetesGestational diabetesMedDRA version: 14.1Level: LLTClassification code 10018210Term: Gestational diabetes mellitusSystem Organ Class: 100000004868EUCTR2013-000789-13-BEVU University Medical Center154
已完成
不适用
Vitamin D and lifestyle Intervention for gestational diabetes mellitus (GDM) preventioGestational diabetesPregnancy and ChildbirthDiabetes mellitus in pregnancyISRCTN70595832VU University Medical Center (Netherlands)880
已完成
3 期
Vitamin D And Lifestyle Intervention for Gestational Diabetes Mellitus (GDM) Prevention - A European multicentre, randomised trial: Vitamin D limb.gestational diabetes10026908NL-OMON39823Vrije Universiteit Medisch Centrum44
进行中（未招募）
不适用
DALI: finding the right intervention for the prevention of gestationaldiabetesEUCTR2013-000789-13-ATVU University Medical Center440
已完成
不适用
Improving vitamin D status and related health in young women (part-A)–cross-section studyACTRN12617000927325Prof John D Wark468