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临床试验/NCT01038453
NCT01038453Unknown不适用

Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation

University of Aarhus1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2009年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Birth Weight

研究概览

简要总结

The purpose of this study is to determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •P-OH25-vitamin D < 50 nmol/l
  • •Woman age 30-35 years
  • •In good general health

排除标准

  • •Infertility
  • •Intake of 400 IU or more Vitamin D/day
  • •Alcohol or drug abuse
  • •Calciummetabolic disturbances
  • •Spontaneous abortion within last 6 month

研究组 & 干预措施

Cholecalciferol (Vitamin D3) 35 µg

Active Comparator

Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day

干预措施: Cholecalciferol 35 µg per day (Dietary Supplement)

Cholecalciferol (Vitamin D3) 70 µg

Active Comparator

Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day

干预措施: Cholecalciferol (Vitamin D3) 70 µg (Dietary Supplement)

placebo

Placebo Comparator

干预措施: placebo tablet (Other)

结局指标

主要结局

Birth Weight

时间窗: 0-24 hours after delivery of the child

次要结局

  • Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).(Day 1 to 4 months after delivery.)
  • Infections of the newborn(Day 1 of the child to 16 weeks after birth.)
  • Growth of the newborn measured by weight, crown-heel length and head circumference(Day 1 of the child to 16 weeks after birth)
  • Time to accomplish pregnancy(0-12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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