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

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Pre-Eclampsia
• Intervention / Treatment: Drug: 400 IU Vitamin D3; Drug: 4000 IU Vitamin D3

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 Type: Interventional
• Enrollment (Actual): 179
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 400 IU Vitamin D3; 400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.	Drug: 400 IU Vitamin D3; Antenatal multivitamin; Other Names: Materna
Experimental: 4000 IU Vitamin D3; 4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.	Drug: 4000 IU Vitamin D3; 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily; Other Names: Vidrop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Fahad Medical City

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): October 31, 2014
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: February 24, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy; Insufficiency; Pre-eclampsia; Deficiency; IUGR; Maternal vitamin D
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Pregnancy Complications; Hypertension, Pregnancy-Induced; Vitamin D Deficiency; Eclampsia; Pre-Eclampsia; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: IRB00008644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No