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

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ClinicalTrials.gov Identifier: NCT05659173
Recruitment Status : Recruiting
First Posted : December 21, 2022
Last Update Posted : June 22, 2023
Sponsor:
Collaborator:
Ministry of Higher Education, Malaysia
Information provided by (Responsible Party):
Nurul Iftida Binti Basri, Universiti Putra Malaysia

Study Description
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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.

Condition or disease Intervention/treatment
Hypertensive Disorder of Pregnancy Vitamin D Deficiency Diagnostic Test: Blood taking

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 Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official 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
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : March 28, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Groups and Cohorts
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Group/Cohort Intervention/treatment
1- normotensive women
Women with vitamin D deficiency and normotensive during pregnancy
 Diagnostic Test: Blood taking
Blood test for vitamin D level and DNA extraction for VDR gene polymorphism
2- women with hypertensive disorder in pregnancy
Women with Vitamin D deficiency and hypertensive disorder in pregnancy
 Diagnostic Test: Blood taking
Blood test for vitamin D level and DNA extraction for VDR gene polymorphism


Outcome Measures
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Venous blood for vitamin D level and genomic DNA decsription

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All Malaysia pregnant women attending Obstetrics and Gynaecology Department of Hospital Pengajar UPM(HPUPM) and Hospital Serdang who fulfilled the criteria will be recruited.
Criteria

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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05659173


Contacts
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Contact: Nurul I Basri 0397699339 nurul.iftida@upm.edu.my

Locations
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Malaysia
Hospital Pengajar UPM Recruiting
Serdang, Selangor Darul Ehsan, Malaysia, 43400
Contact: Nurul I Binti Basri    0133452294    nurul.basri@yahoo.co.uk   
Sub-Investigator: Amilia A Mohd Jamil         
Principal Investigator: Nurul I Basri         
Sub-Investigator: Norshariza Nordin         
Sub-Investigator: Su Peng Loh         
Sub-Investigator: Aida Mohd Jamil         
Sub-Investigator: Yakubu Ibrahim         
Sponsors and Collaborators
Universiti Putra Malaysia
Ministry of Higher Education, Malaysia
Investigators
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Principal Investigator: Nurul I Basri, MbChb Universiti Putra Malaysia
More Information
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Responsible Party: Nurul Iftida Binti Basri, Dr, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT05659173    
Other Study ID Numbers: FRGS/1/2022/SKK01/UPM/02/1
First Posted: December 21, 2022    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Toxemia
Hypertension, Pregnancy-Induced
Hypertension
Vitamin D Deficiency
Vascular Diseases
Cardiovascular Diseases
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Infections