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

NCT05659173 | Active Not Recruiting

• 1 other identifier: FRGS/1/2022/SKK01/UPM/02/1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Disorder of Pregnancy; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (6)

• Prevalence of vitamin D deficiency

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

  1 year

• Risk factors of vitamin D deficiency

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

  1 year

• Risk factors of vitamin D deficiency

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

  1 year

• Risk factors of vitamin D deficiency

  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

  1 year

• VDR allele and genotype

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

  1 year

• VDR-combined genotypes and gestational hypertension

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

  6 months

Study Arms (2)

1- normotensive women

Women with vitamin D deficiency and normotensive during pregnancy

Diagnostic Test: Blood taking

2- women with hypertensive disorder in pregnancy

Women with Vitamin D deficiency and hypertensive disorder in pregnancy

Diagnostic Test: Blood taking

Interventions

Blood taking DIAGNOSTIC_TEST

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

1- normotensive women; 2- women with hypertensive disorder in pregnancy

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Ministry of Higher Education, Malaysia: collaborator

Study Sites (1)

Hospital Pengajar UPM

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (1)

• Ibrahim Y, Basri NI, Nordin N, Mohd Jamil AA. Vitamin D Deficiency and Its Association With Vitamin D Receptor Gene Variants Among Malaysian Women With Hypertensive Disorders in Pregnancy: Protocol for a Nutrigenomics Study. JMIR Res Protoc. 2024 Mar 26;13:e53722. doi: 10.2196/53722.

  PMID: 38530345 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood for vitamin D level and genomic DNA decsription

MeSH Terms

Conditions

Toxemia; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Infections; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Nurul I Basri, MbChb

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: December 21, 2022
• Study Start: December 1, 2022
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)