Vitamin D Deficiency With Selected Vitamin D Receptor Gene Polymorphism in Gestational Hypertension

Recruiting

• Conditions: Hypertensive Disorder of Pregnancy; Vitamin D Deficiency
• Interventions: Diagnostic Test: Blood taking

• Registration Number: NCT05659173
• Lead Sponsor: Universiti Putra Malaysia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-12-17
• Study First Posted: 2022-12-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-03-28
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

1. 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)
2. Malay pregnant women with viable pregnancy with or without pregnancy induced hypertension or its complications (pre-eclampsia, eclampsia, HELLP syndrome etc).
3. Literate in either English or Malay languages.
4. Agreement to follow-up till delivery and provision of written informed consent.

Read More

Exclusion Criteria

1. Non-viable pregnancy at the time of recruitment.
2. Women already on vitamin D supplements or any other drugs that can interfere with vitamin D absorption or metabolism at the time of recruitment.
3. Women with chronic hypertension diagnosed prior to pregnancy.
4. Pregnant women with any other chronic disease that is known to affect vitamin D such as, autoimmune disease and any malignancy

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1- normotensive women	Blood taking	Women with vitamin D deficiency and normotensive during pregnancy
2- women with hypertensive disorder in pregnancy	Blood taking	Women with Vitamin D deficiency and hypertensive disorder in pregnancy

Primary Outcome Measures

Name	Time	Method
VDR allele and genotype	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	1 year	To determine the prevalence of Vitamin D deficiency among Malaysian pregnant mothers
Risk factors of vitamin D deficiency	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	6 months	To associate VDR-combined genotypes with the risk to develop gestational hypertension in vitamin D deficient Malay pregnant women

Trial Locations

Locations (1)

Hospital Pengajar UPM; 🇲🇾 Serdang, Selangor Darul Ehsan, Malaysia