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RecruitingNCT07288801Updated Dec 17, 2025

Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women

A Phase 4 interventional study of Vitamin D and Placebo and standard of care in Pre-eclampsia, Pregnancy and Vitamin D, sponsored by Nishtar Medical University. Recruiting at 1 site in Pakistan. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Nishtar Medical University · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Aug 2025, registered Dec 2025).
  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pre-eclampsia
  • Pregnancy
  • Vitamin D

Keywords

  • pre-eclampsia
  • pregnancy
  • recurrence
  • Vitamin D
03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 146 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pre-existing hypertension, cardiac diseases, renal disease, thyrotoxicosis (on history and medical record)
  • Women presenting with intra-uterine death of the fetus.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
146 participants (estimated)

Study arms

  • Experimental
    Intervention

    Oral supplementation with high dose vitamin D

    Drug: Vitamin D

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo and standard of care

Interventions

  • DrugVitamin D

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

  • DrugPlacebo and standard of care

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

    Also known as: Placebo

06

What researchers measure

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

    Time frame: From enrollment till 36 completed weeks of gestation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Feb 2026, 5 months after the start.

Of 35 phase 4 interventional studies under Pre-Eclampsia, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 35. This study's planned 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2025
First posted
Dec 17, 2025
StartActual
Aug 9, 2025
Primary completionEst.
Feb 8, 2026
CompletionEst.
Feb 8, 2026
Last update
Dec 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07288801
Lead sponsor
Nishtar Medical University
Responsible party
Dr. Tehseen Aslam (Principal Investigator, Nishtar Medical University) — Principal investigator
First posted
Dec 17, 2025
Start date
Aug 9, 2025
Primary completion
Feb 8, 2026 (estimated)
Completion
Feb 8, 2026 (estimated)
Last update
Dec 17, 2025

Study contacts

Tehseen A Principal Investigator, MBBS
Contact
tehseenaslam451@gmail.com
+92 303 7832417
Mehnaz K Professor, FCPS
study chair · Nishtar Medical University and Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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