Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Maternal and Neonatal complications
研究概览
简要总结
Vitamin D deficiency is wide spread in South Asian population and is contributing to burden of disease in this region including Pakistan. The relative importance of vitamin D deficiency, mutation in its receptor and maternal and child health has not been established in Pakistan and population based studies are required to explore and avert the maternal and Neonatal complications and consequences of Vitamin D deficiency
The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and their Infants. It will be a double blind placebo controlled trial, which will be conducted in a rural district of Pakistan.
详细描述
The investigators are proposing a community based introduction of vitamin D supplementation and we intend to understand the complex relationship between vitamin D, the growth factors and maternal and infant anthropometric variables and hope to unravel the reasons of vitamin D deficiency in our population.
The investigators expect that if vitamin D is supplemented to pregnant women and their newborn infants it will inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women from 20-22 weeks of gestation and their infants, who will 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
- •Women with multiple fetuses, babies (twins, triplets)
- •Pregnant women with high level of Vitamin D
- •Babies with multiple congenital anomalies
- •Babies with serious birth injury, birth asphyxia and serious infections
- •Low birth weight less than 1.5
- •Refuse to participate in the study
结局指标
主要结局
Maternal and Neonatal complications
时间窗: six months post enrolement
Preeclampsia, hypertension ,poor weight gain etc during pregnancy.Still birth rates, Rate of low birth weight, prematurity,Neonatal seizures, Infants with growth failure, signs and symptoms of vitamin D deficiency. Infants with infections: pneumonia, diarrhea and Receptor polymorphism
次要结局
- Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency(Six months post recruitment)
研究者
Dr Zulfiqar Ahmed Bhutta
Professor and Founding Chair, Division of Women and Child Health
Aga Khan University