Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 179
- 主要终点
- Number of Participants With Pre-eclampsia in Both Arms
研究概览
简要总结
Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.
详细描述
Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage.
Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent.
- •Planned to receive antenatal care in King Fahad Medical City antenatal clinic.
- •The ability to provide written informed consent at the first visit.
- •Low risk pregnancy; and Serum vitamin D3 levels less than < 25nmol/L.
排除标准
- •Mothers with pregnancy with abnormal foetus.
- •Previous history of hypertension, pre-eclampsia, recurrent miscarriages.
- •Chronic kidney disease, chronic liver disease, and malignancy.
研究组 & 干预措施
400 IU Vitamin D3
400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.
干预措施: 400 IU Vitamin D3 (Drug)
4000 IU Vitamin D3
4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.
干预措施: 4000 IU Vitamin D3 (Drug)
结局指标
主要结局
Number of Participants With Pre-eclampsia in Both Arms
时间窗: From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.
Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.
次要结局
- Change in Vitamin D Level(At 36th week of pregnancy)
- Number of Patients With Intrauterine Growth Retardation(At delivery)
研究者
Aisha Mansoor Ali
Assistant Consultant Obstetric and Gynecology
King Fahad Medical City