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NCT Number: NCT07717931

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

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.

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Key information

Conditions

Preeclampsia Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CMH Multan Institute of Medical Sciences

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Recurrence of Preeclampsia

    Time frame: From randomization until 36 weeks of gestation

    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.

Sponsors and collaborators

Lead sponsor

CMH Multan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Preventing Preeclampsia Recurrence in High-Risk Pregnancies Using Vitamin D Therapy: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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