Hypertensive Disorder of PregnancyNCT05659173
Vitamin D Deficiency With Selected Vitamin D Receptor Gene Polymorphism in Gestational Hypertension
An observational study of Hypertensive Disorder of Pregnancy and Vitamin D Deficiency, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Vitamin D Deficiency
- What is being tested?
- Blood taking
- How many people
- 180 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Blood taking
- Medical subject headings
- Toxemia, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood takingDiagnostic test
Blood test for vitamin D level and DNA extraction for VDR gene polymorphism
| Study group | Role | What they receive |
|---|---|---|
| 1- normotensive women | Women with vitamin D deficiency and normotensive during pregnancy Receives: Diagnostic Test: Blood taking | |
| 2- women with hypertensive disorder in pregnancy | Women with Vitamin D deficiency and hypertensive disorder in pregnancy Receives: Diagnostic Test: Blood taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vitamin D deficiency
To determine the prevalence of Vitamin D deficiency among Malaysian pregnant mothers
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 year
VDR allele and genotype
To understand and associate distributions of VDR allele and genotype with vitamin D deficiency among Malay pregnant mothers
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Dec 2022
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Responsible party
- Principal investigator, Nurul Iftida Binti Basri, Universiti Putra Malaysia
- Investigators
- Nurul I Basri, MbChb, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659173
- Sponsor's protocol ID
- FRGS/1/2022/SKK01/UPM/02/1
- Status last verified
- Jun 2025
- First submitted
- 6 Nov 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38530345
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05659173
- Acronym / sponsor ID
- FRGS/1/2022/SKK01/UPM/02/1
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- normotensive women | – | Diagnostic Test: Blood takingWomen with vitamin D deficiency and normotensive during pregnancy |
| 2- women with hypertensive disorder in pregnancy | – | Diagnostic Test: Blood takingWomen with Vitamin D deficiency and hypertensive disorder in pregnancy |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood takingBlood test for vitamin D level and DNA extraction for VDR gene polymorphism | Diagnostic test | 1- normotensive women, 2- women with hypertensive disorder in pregnancy |
Primary outcome
Prevalence of vitamin D deficiency
Time frame: 1 year
To determine the prevalence of Vitamin D deficiency among Malaysian pregnant mothers
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.
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 38530345Ibrahim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurul I Basri, MbChb principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disorder of Pregnancy and Vitamin D Deficiency, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of vitamin D deficiency (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.