Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- pregnancy out come
研究概览
简要总结
The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the study participants will receive Vitamin D in supplement form. Pregnant women will be individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till the time of delivery.A blood sample will also be collected from the participant at the time of recruitment /before the starting of the supplementation for the assessment of Calcium, Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D level to assess vitamin D status will be done after completion of the supplementation phase at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan University laboratory
详细描述
The investigators hypothesize that Pakistani mothers as darkly pigmented, will require substantially higher oral supplementation with vitamin D to replenish the micronutrient stores and aid to resolve associated maternal and neonatal morbidity due to Vitamin D deficiency. The investigators expect that if vitamin D is supplemented to pregnant women, their newborn infants would inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.This is hospital based double blinded trial, study participants divided into three groups which will receive Vitamin D supplementation in 400, 2000 and 4000 International Units. The group which will receive 400 IUs will be treated as control group.
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, Investigator)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged 15 - 45 years
- •Less than 16 weeks pregnant from Last menstrual period.
- •Agree to take part in this study, will be enrolled.
排除标准
- •Pregnant women with pre existing type 1 or type II diabetes,
- •Pregnant women with pre existing hypertension
- •Women with multiple fetuses, babies (twins, triplets)
- •Women with fetal anomaly in scan
- •Refuse to participate in the study
研究组 & 干预措施
Intervention Group
Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,
干预措施: Vitamin D supplement (Drug)
Arm 2 intervention group
Arm 2 is receiving vitamin D supplementation in 4000/IU per day
干预措施: Vitamin D supplement (Drug)
Arm 3 control group
Arm 3 is receiving vitamin D supplementation in 400 IU/day
干预措施: Vitamin D supplement (Drug)
结局指标
主要结局
pregnancy out come
时间窗: At delivery of neonate
Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.
次要结局
- Prevalence of vitamin D deficiency in pregnant women(at recruitment into study (first trimester))
研究者
Dr Sidrah Nausheen
Principal Investigator
Aga Khan University