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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Vitamin D Deficiency Pre-Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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400 IU Vitamin D3

400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.

Group Type ACTIVE_COMPARATOR

400 IU Vitamin D3

Intervention Type DRUG

Antenatal multivitamin

4000 IU Vitamin D3

4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.

Group Type EXPERIMENTAL

4000 IU Vitamin D3

Intervention Type DRUG

4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily

Interventions

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400 IU Vitamin D3

Antenatal multivitamin

Intervention Type DRUG

4000 IU Vitamin D3

4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily

Intervention Type DRUG

Other Intervention Names

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Materna Vidrop

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes