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

Phase 1

Completed

• Conditions: Vitamin D Deficiency; Pre-Eclampsia
• Interventions: Drug: 400 IU Vitamin D3; Drug: 4000 IU Vitamin D3

• Registration Number: NCT03101150
• Lead Sponsor: King Fahad Medical City

Brief 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.

Study Timeline

• Study Start: 2012-10-01
• Primary Completion: 2014-10-31
• Study Completion: 2015-12-31
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Results First Submitted: 2017-04-06
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-24
• Last Update Submitted: 2018-02-24
• Results First Posted: 2018-11-02
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 179

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 IU Vitamin D3	400 IU Vitamin D3	400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.
4000 IU Vitamin D3	4000 IU Vitamin D3	4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Vitamin D Level	At 36th week of pregnancy	Level of Improvement in Vitamin D status in both arms
Number of Patients With Intrauterine Growth Retardation	At delivery	Patients having fetus with retardation of growth in both arms.