Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT03101150
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
Sponsor:
King Fahad Medical City
Organization:
Study Overview
Official Title:
Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: