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
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Tracking Information | |||||
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First Submitted Date | November 6, 2022 | ||||
First Posted Date | December 21, 2022 | ||||
Last Update Posted Date | June 22, 2023 | ||||
Actual Study Start Date | November 1, 2022 | ||||
Estimated Primary Completion Date | March 28, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Vitamin D Deficiency With Selected Vitamin D Receptor Gene Polymorphism in Gestational Hypertension | ||||
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 | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Venous blood for vitamin D level and genomic DNA decsription
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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. | ||||
Condition |
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Intervention | Diagnostic Test: Blood taking
Blood test for vitamin D level and DNA extraction for VDR gene polymorphism
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
180 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | September 30, 2024 | ||||
Estimated Primary Completion Date | March 28, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 19 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | Malaysia | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT05659173 | ||||
Other Study ID Numbers | FRGS/1/2022/SKK01/UPM/02/1 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Nurul Iftida Binti Basri, Universiti Putra Malaysia | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Universiti Putra Malaysia | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Ministry of Higher Education, Malaysia | ||||
Investigators |
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PRS Account | Universiti Putra Malaysia | ||||
Verification Date | June 2023 |