Association of Vitamin D Deficiency With Selected Vitamin D Receptor (VDR) Gene Polymorphism in Gestational Hypertension Among Malaysian Women: A Prospective Genetic Biomarker for Early Intervention Strategy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- VDR allele and genotype
研究概览
简要总结
This study aim to look into the prevalence of Vitamin D deficiency among Malaysian pregnant women and its associated risk factors. Subsequently, vitamin D deficient women with and without gestational hypertension will be investigated for their genetic variation to look for the association of VDR genetic variation and hypertensive disorders in pregnancy.
详细描述
Hypertensive disorders of pregnancy account for approximately 14% of maternal mortality globally and is the fourth leading cause of maternal mortality in Malaysia. Despite this, the mechanisms and pathogenesis are still unknown. Vitamin D deficiency (hypovitaminosis vitamin D) has been shown to be one of the causes of gestational hypertension(GH).
Several populations have observed the association of single nucleotide polymorphisms (SNPs) of vitamin D receptor (VDR) to vitamin D deficiency among pregnancy complications, including GH. Alarming cases of hypovitaminosis D in sunny areas including Malaysia, highly imply the need to understand the genetic factor. Hence, genotyping VDR variants among pregnant women is essential for early vitamin D supplementation strategy. To investigators knowledge, there has been no published study conducted among Malaysian population on the association of VDR genetic variation and GH. Therefore, this study aim to investigate the prevalence of vitamin D deficiency and its association of VDR SNPs to the development of GH among Malaysian pregnant mothers, with the main focus on Malays, representing the largest ethnic in Malaysia.
The prevalence will be determined through a cross-sectional study involving 363 pregnant women recruited in Hospital Pengajar UPM (HPUPM) and Hospital Serdang, Selangor. Relevant socio-demographic, clinical and anthropometric data will be collected using structured interviewer-administered questionnaire. Blood specimens for the analysis of vitamin D will be done. The association will be determined in a case-control study involving 180 pregnant women who fulfilled the criteria, recruited from phase 1 study. Their blood will be further analysed for the variants of the VDR gene [(BsmI(rs1544410), FokI(rs2228570), TaqI(rs731236)] to look for the association.
This study expected to provide more evidence for early personalised intervention of vitamin D supplementation due to anticipated individual genetic variability. This antenatal care programme will reduce the government expenditures, reduce maternal and fetal morbidity and mortality while strengthening Malaysia's healthcare system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Malay pregnant women with gestational age between 20 weeks till 42 weeks. (The gestational age will be determined from the first day of the last menstrual cycle or measurement of fetal crown rump length)
- •Malay pregnant women with viable pregnancy with or without pregnancy induced hypertension or its complications (pre-eclampsia, eclampsia, HELLP syndrome etc).
- •Literate in either English or Malay languages.
- •Agreement to follow-up till delivery and provision of written informed consent.
排除标准
- •Non-viable pregnancy at the time of recruitment.
- •Women already on vitamin D supplements or any other drugs that can interfere with vitamin D absorption or metabolism at the time of recruitment.
- •Women with chronic hypertension diagnosed prior to pregnancy.
- •Pregnant women with any other chronic disease that is known to affect vitamin D such as, autoimmune disease and any malignancy
结局指标
主要结局
VDR allele and genotype
时间窗: 1 year
To understand and associate distributions of VDR allele and genotype with vitamin D deficiency among Malay pregnant mothers
Prevalence of vitamin D deficiency
时间窗: 1 year
To determine the prevalence of Vitamin D deficiency among Malaysian pregnant mothers
Risk factors of vitamin D deficiency
时间窗: 1 year
To determine the associated risk factors of vitamin D deficiency among Malaysian pregnant mothers-intake of food rich in vitamin D, measured in serving number per week
VDR-combined genotypes and gestational hypertension
时间窗: 6 months
To associate VDR-combined genotypes with the risk to develop gestational hypertension in vitamin D deficient Malay pregnant women
次要结局
未报告次要终点
研究者
Nurul Iftida Binti Basri
Dr
Universiti Putra Malaysia