DRKS00010769招募中未知
Influence of vitamin B6 on nausea (Nausea gravidarum)
eibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung0 个研究点目标入组 150 人开始时间: 2016年7月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •Women with confirmed pregnancy to the end of the 10th week of pregnancy,
- •acute nausea during pregnancy (Nausea gravidarum)
排除标准
- •deterioration of nausea gravidarium during the study period of two weeks;
- •intake of vitamin B6 supplements over 2 mg/day;
- •taking any medications against nausea and vomiting;
- •previous hospitalization due to nausea gravidarum;
- •BMI =30kg/m2;
- •Blood pressure: >160mmHg systolic or >100mmHg diastolic;
- •multiple pregnancy;
- •known complications in an earlier pregnancy (e.g. premature delivery, miscarriage, placental abnormalities, fetal anomaly);
- •severe chronic illness (manifest coronary heart disease, cancer);
- •insulin-dependent diabetes mellitus Typ I and II;
- •severe kidney or liver diseases;
- •conditions after gastrointestinal surgical procedure and chronic gastrointestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas), e.g. gastrectomy, celiac diseases, chronic pancreatitis, cholestasis, short bowel syndrome, chronic inflammatory bowel disease (except appendicitis, gallstone surgery);
- •hormonal disorders, for example, Cushing's syndrome and untreated hyperthyroidism;
- •addiction (alcohol, drugs and/or medications);
- •missing consent;
- •refusing / reset of the consent;
- •simultaneous participation in another clinical trial or participation within the last 30 days;
- •planned surgery within the next three month
研究者
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