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NCT Number: NCT05659173

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

19 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Pengajar UPM

Serdang, Selangor, 43400, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Blood Taking

Diagnostic Test

Blood test for vitamin D level and DNA extraction for VDR gene polymorphism

Primary outcomes

  1. Prevalence of vitamin D deficiency

    Time frame: 1 year

    To determine the prevalence of Vitamin D deficiency among Malaysian pregnant mothers

  2. Risk factors of vitamin D deficiency

    Time frame: 1 year

    To determine the associated risk factors of vitamin D deficiency among Malaysian pregnant mothers-weight, height and BMI will be measured in kg/m2.

  3. Risk factors of vitamin D deficiency

    Time frame: 1 year

    To determine the associated risk factors of vitamin D deficiency among Malaysian pregnant mothers-duration of sun exposure in a week, measured in hours

  4. Risk factors of vitamin D deficiency

    Time frame: 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

  5. VDR allele and genotype

    Time frame: 1 year

    To understand and associate distributions of VDR allele and genotype with vitamin D deficiency among Malay pregnant mothers

  6. VDR-combined genotypes and gestational hypertension

    Time frame: 6 months

    To associate VDR-combined genotypes with the risk to develop gestational hypertension in vitamin D deficient Malay pregnant women

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • Ministry of Higher Education, Malaysia

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2022
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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