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

King Fahad Medical City

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pre-Eclampsia; Vitamin D Deficiency

Treatments: Drug: 4000 IU Vitamin D3; Drug: 400 IU Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT03101150

IRB00008644

Details and patient eligibility

About

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.

Full 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.

Enrollment: 179 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

400 IU Vitamin D3

Active Comparator group

Description:

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

Treatment:

Drug: 400 IU Vitamin D3

4000 IU Vitamin D3

Experimental group

Description:

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

Treatment:

Drug: 4000 IU Vitamin D3