Vitamin D Therapy to Prevent Recurrent Preeclampsia in High-Risk Pregnancies

NCT07717931 | Completed Phase 4

• 1 other identifier: U1111-1343-7979
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether vitamin D supplementation can reduce the recurrence of preeclampsia in pregnant women with a previous history of preeclampsia. The main questions the study aims to answer are: \- Does daily vitamin D supplementation reduce the recurrence of preeclampsia compared with a placebo? Researchers will randomly assign 146 eligible pregnant women to receive either vitamin D supplements or a placebo. The two groups will be compared to determine whether vitamin D lowers the risk of recurrent preeclampsia. Participants will:

• Be randomly assigned to receive either 4000 IU oral vitamin D once daily or a matching placebo.
• Take the assigned study medication daily until 36 weeks of gestation.
• Attend follow-up visits every 2 weeks for blood pressure measurement and clinical assessment.
• Have serum vitamin D levels measured every 4 weeks to monitor for vitamin D toxicity.
• Undergo urine testing for protein if blood pressure is elevated to assess for preeclampsia. The results of this study will help determine whether vitamin D supplementation is an effective and safe strategy for preventing recurrent preeclampsia in women at high risk.

Conditions

Preeclampsia

Keywords

Vitamin D; Cholecalciferol; Preeclampsia Recurrence; High-Risk Pregnancy; Pregnancy-Induced Hypertension; Placebo

Outcome Measures

Primary Outcomes (1)

• Recurrence of Preeclampsia

  Recurrence of preeclampsia will be defined as the development of new-onset hypertension (blood pressure ≥140/90 mmHg) and proteinuria (≥1+ on urine dipstick) at 20 weeks of gestation or later in women with a previous history of preeclampsia. Participants with elevated blood pressure will undergo urine protein testing to confirm the diagnosis.

  From randomization until 36 weeks of gestation

Study Arms (2)

Vitamin D Supplementation

EXPERIMENTAL

Participants randomized to this arm will receive oral vitamin D

Drug: Vitamin D (Cholecalciferol )

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm will receive a matching placebo with the same taste, color, and consistency as the active treatment

Drug: Placebo

Interventions

Placebo DRUG

A matching placebo with the same taste, color, and consistency as vitamin D will be administered orally once daily from enrollment until 36 weeks of gestation for comparison with vitamin D supplementation.

Placebo

Vitamin D (Cholecalciferol ) DRUG

Vitamin D 4000 IU will be administered orally once daily from enrollment until 36 weeks of gestation. They will attend follow-up visits every 2 weeks for blood pressure monitoring and clinical assessment, with serum vitamin D levels measured every 4 weeks.

Vitamin D Supplementation

Eligibility Criteria

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

You may qualify if:

• Pregnant women
• Singleton pregnancy (on USG)
• Gestational age ≥ 24-weeks (on LMP method) and
• Past medical history of pre-eclampsia (on medical record)

You may not qualify if:

• Pre-existing chronic hypertension
• Cardiac diseases (congenital or acquired)
• Renal disease
• Thyrotoxicosis (on history and medical record) and
• Intra-uterine death of the fetus.

Sponsors & Collaborators

• CMH Multan Institute of Medical Sciences: lead

Study Sites (1)

CMH Multan Institute of Medical Sciences

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Nidda Y Assistant Professor, FCPS

  CMH Multan Institute of Medical Sciences

  STUDY CHAIR

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 GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)