High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
研究概览
简要总结
The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.
详细描述
Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are within the ages of 18-45 years
- •In good general health
- •12 weeks pregnant (based on last menstrual period)
排除标准
- •Mothers with preexisting type I or type II diabetes
- •Mothers with preexisting hypertension
- •Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
- •Mothers with multiple fetuses (e.g., twins, triplets, etc.)
研究组 & 干预措施
Prenatal Vitamin D3
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D
干预措施: Prenatal Vitamin (Drug)
2
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
干预措施: Prenatal Vitamin (Drug)
2
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
干预措施: Cholecalciferol (Vitamin D3) (Drug)
3
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
干预措施: Prenatal Vitamin (Drug)
3
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
干预措施: Cholecalciferol (Vitamin D3) (Drug)
结局指标
主要结局
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
时间窗: 12, 16, 28 weeks and at maternal delivery and neonatal birth
Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement
次要结局
- Birthweight of Newborn Infant(Measured at birth.)
- Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth(At delivery)