Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women

Role of Vitamin D in Prevention of Preeclampsia Recurrence in Pregnant Women With Previous History of Preeclampsia: A Randomized Controlled Trial

The goal of this clinical trial is to find out whether giving vitamin D to pregnant women who had pre-eclampsia in a previous pregnancy helps prevent the condition from coming back. The main question it aims to answer is:

Does vitamin D supplementation reduce the chance of pre-eclampsia recurring in pregnant women with a history of pre-eclampsia?

To answer this question, pregnant women attending the antenatal clinic at the Department of Obstetrics and Gynaecology, Nishtar Hospital Multan will be invited to join the study.

Participants will be randomly assigned to two equal groups:

• Vitamin D group: will take 4,000 IU of oral vitamin D until 36 weeks of gestation.
• Placebo group: will receive a pill identical in appearance, taste, and consistency but without vitamin D.

While on the study medication, each woman will visit the clinic every two weeks. At each visit, her blood pressure will be measured, and if it is 140/90 mmHg or higher, a urine test will check for protein to identify pre-eclampsia as per hospital protocol. Any diagnosis of pre-eclampsia will lead to standard care, and the outcome will be recorded.

At the end, researchers will compare how many women in each group developed recurrent pre-eclampsia.

This study will help answer whether vitamin D supplementation can safely reduce the risk of pre-eclampsia returning in women with a prior history - a question important for improving pregnancy outcomes and maternal health.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Pre-eclampsia; Vitamin D
• Intervention / Treatment: Drug: Vitamin D; Drug: Placebo and standard of care

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tehseen A Principal Investigator, MBBS; Phone Number: +92 303 7832417; Email: tehseenaslam451@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Multan, Punjab Province, Pakistan, 60000
      • Recruiting
      • Nishtar Medical University and Hospital
      • Contact: Tehseen A Principal Investigator, MBBS; Phone Number: +92 303 7832417; Email: tehseenaslam451@gmail.com
      • Contact: Mehnaz K Professor, FCPS; Phone Number: +92 333 6131713; Email: mehnazkhakwani713@gmail.com
      • Principal Investigator: Tehseen A Principal Investigator, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gestational age ≥ 20-weeks (on LMP method) ' - Past medical history of pre-eclampsia

Exclusion Criteria:

• Pre-existing hypertension, cardiac diseases, renal disease, thyrotoxicosis (on history and medical record)
• Women presenting with intra-uterine death of the fetus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo and standard of care; Look, smell and taste alike oil emulsion drops, same number, till 36-weeks of gestation; Other Names: Placebo
Experimental: Intervention; Oral supplementation with high dose vitamin D	Drug: Vitamin D; 4000 IU of vitamin D will be given orally, once daily till 36-weeks of gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-eclampsia	Pregnant women, ≥ 20-weeks of gestation (on LMP method) having blood pressure of ≥140/90 mm of Hg plus protein (+1 or higher) in spot urine examination by dipstick method	From enrollment till 36 completed weeks of gestation

Collaborators and Investigators

• Sponsor: Nishtar Medical University
• Investigators: Study Chair: Mehnaz K Professor, FCPS, Nishtar Medical University and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2025
• Primary Completion (Estimated): February 8, 2026
• Study Completion (Estimated): February 8, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Vitamin D; pregnancy; recurrence; pre-eclampsia
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pathological Conditions, Signs and Symptoms; Pre-Eclampsia; Recurrence; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Polycyclic Compounds; Quality Indicators, Health Care; Steroids; Fused-Ring Compounds; Secosteroids; Vitamin D; Standard of Care
• Other Study ID Numbers: U1111-1332-4347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No