Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women

NCT07288801 | Recruiting Phase 4

• 1 other identifier: U1111-1332-4347
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D; Pre-eclampsia; Pregnancy

Keywords

pre-eclampsia; pregnancy; recurrence; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Oral supplementation with high dose vitamin D

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo and standard of care

Interventions

Vitamin D DRUG

4000 IU of vitamin D will be given orally, once daily till 36-weeks of gestation

Intervention

Placebo and standard of care DRUG

Look, smell and taste alike oil emulsion drops, same number, till 36-weeks of gestation

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University and Hospital

Multan, Punjab Province, 60000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Recurrence

Interventions

Vitamin D; Standard of Care

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mehnaz K Professor, FCPS

  Nishtar Medical University and Hospital

  STUDY CHAIR

Central Study Contacts

Tehseen A Principal Investigator, MBBS

CONTACT

+92 303 7832417; tehseenaslam451@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: August 9, 2025
• Primary Completion: February 8, 2026
• Study Completion: February 8, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)