NCT02021864Unknown不适用
Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia
Dr. Sima Hashemipour1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- percentage of hypocalcemic subjects at the ens of study
研究概览
简要总结
- Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study. .
- Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs.
- Participants will randomly assigned in to two groups of intervention and control groups .Randomization will be done by random number generator. Intervention group will receive weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily prenatal multivitamin.
- At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length, weight, head circumference ) will be compared between two groups.
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
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •gestational age of 24-26weeks,mild hypocalcemia (ca=8-8.6mg/dl),singleton pregnancy, body mass index (BMI) of 19-26 -
排除标准
- •moderate to sever hypocalcemia(ca<8mg/dl), gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs
研究组 & 干预措施
vitamin D3, prenatal multivitamin
Experimental
vitamin D3 50,000 unit/week for 8 weeks, daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
干预措施: vitamin D3 50,000 unit (Drug)
vitamin D3, prenatal multivitamin
Experimental
vitamin D3 50,000 unit/week for 8 weeks, daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
干预措施: prenatal multivitamin (Drug)
prenatal multivitamin
Active Comparator
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
干预措施: prenatal multivitamin (Drug)
结局指标
主要结局
percentage of hypocalcemic subjects at the ens of study
时间窗: 12-14 weeks
women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.
次要结局
- Changing of maternal mean calcium level(12-14 weeks)
研究者
Dr. Sima Hashemipour
assistant professor of endocrinology and metabolism
Sina Hospital, Iran
研究点 (1)
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