Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia

Study Overview
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Brief Summary
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Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.

Detailed Description
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Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage. Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.

Official Title
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Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia

Conditions
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Vitamin D Deficiency, Pre-Eclampsia

Intervention / Treatment
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* Drug: 400 IU Vitamin D3
* Drug: 4000 IU Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent. Planned to receive antenatal care in King Fahad Medical City antenatal clinic. The ability to provide written informed consent at the first visit. Low risk pregnancy; and Serum vitamin D3 levels less than < 25nmol/L. Exclusion Criteria: Mothers with pregnancy with abnormal foetus. Previous history of hypertension, pre-eclampsia, recurrent miscarriages. Chronic kidney disease, chronic liver disease, and malignancy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 400 IU Vitamin D3<br>400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery. | Drug: 400 IU Vitamin D3<br>* Antenatal multivitamin<br>* Other names: Materna;|
| Experimental: 4000 IU Vitamin D3<br>4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery. | Drug: 4000 IU Vitamin D3<br>* 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily<br>* Other names: Vidrop;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Pre-eclampsia in Both Arms | Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose. | From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vitamin D Level | Level of Improvement in Vitamin D status in both arms | At 36th week of pregnancy | 
| Number of Patients With Intrauterine Growth Retardation | Patients having fetus with retardation of growth in both arms. | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal vitamin D, Deficiency, Insufficiency, Pregnancy, Pre-eclampsia, IUGR