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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101150
• Other study ID #: IRB00008644
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 1, 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: February 2018
• Source: King Fahad Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: December 31, 2015
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Vitamin D Deficiency

Intervention

Drug:
• 400 IU Vitamin D3
Antenatal multivitamin
• 4000 IU Vitamin D3
4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Medical City

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Pre-eclampsia in Both Arms	Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.	From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.
Secondary	Change in Vitamin D Level	Level of Improvement in Vitamin D status in both arms	At 36th week of pregnancy
Secondary	Number of Patients With Intrauterine Growth Retardation	Patients having fetus with retardation of growth in both arms.	At delivery