NCT04591847已完成3 期
Pregnancy Outcomes and Vitamin D Level Among Vitamin D Supplementation During Pregnancy : A Double-blind Randomized Placebo Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum 25-OH vitamin D level in pregnant women
研究概览
简要总结
To compared pregnancy outcome (Serum vitamin D level in mother and infant , preeclampsia rate, preterm birth rate, Infant birth weight, Infant length , APGAR score) between pregnant women who were given vitamin D supplementation and pregnant women who were given placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Thai female
- •Singleton pregnancy
- •Age at 18 years old or more
- •Gestational age at 18-22 weeks
- •Accept to enroll
排除标准
- •Pregnant women who not planned to delivery at Rajavithi hospital
- •Abnormal kidney function
- •Use antiepileptic drugs , or vitamin D supplementation
- •Allergy to vitamin D
- •Who were diagnosed as vitamin D deficiency
研究组 & 干预措施
Vitamin D supplemented group
Experimental
Vitamin D2 20000 IU 1 tab oral weekly start at GA 18 -22 weeks until delivery
干预措施: Vitamin D 2 (Drug)
Placebo group
Experimental
Placebo drug (Appearance same as Vitamin D2) 1 tab oral weekly start at GA 18 -22 weeks until delivery
干预措施: Placebo drug (Drug)
结局指标
主要结局
Serum 25-OH vitamin D level in pregnant women
时间窗: At delivery time
measure in nmol/L
Serum 25-OH vitamin D level in umbilicalcord blood
时间窗: At delivery time
measure in nmol/L
次要结局
- Preeclampsia(During pregnancy until delivery)
- Preterm birth(At delivery time)
- Infant APGAR score(At delivery time)
- Infant birth weight(At delivery time)
- Infant length(At delivery time)
研究者
研究点 (1)
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