NCT03101150

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: King Fahad Medical City · Other Government
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

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

• Vitamin D Deficiency
• Pre-Eclampsia

Interventions

Type	Name	Description
DRUG	400 IU Vitamin D3	Antenatal multivitamin
DRUG	4000 IU Vitamin D3	4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-10-31
• Completion: 2015-12-31
• First posted: 2017-04-04
• Last updated: 2018-11-02
• Results posted: 2018-11-02