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Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women

NCT ID: NCT07288801

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-09

Study Completion Date

2026-02-08

Brief Summary

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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.

Detailed Description

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Conditions

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Pre-eclampsia Pregnancy Vitamin D

Keywords

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pre-eclampsia pregnancy recurrence Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

Oral supplementation with high dose vitamin D

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo and standard of care

Intervention Type DRUG

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

Interventions

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Vitamin D

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

Intervention Type DRUG

Placebo and standard of care

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

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nishtar Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tehseen Aslam

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehnaz K Professor, FCPS

Role: STUDY_CHAIR

Nishtar Medical University and Hospital

Locations

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Nishtar Medical University and Hospital

Multan, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Tehseen A Principal Investigator, MBBS

Role: CONTACT

Phone: +92 303 7832417

Email: [email protected]

Facility Contacts

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Tehseen A Principal Investigator, MBBS

Role: primary

Mehnaz K Professor, FCPS

Role: backup

Other Identifiers

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U1111-1332-4347

Identifier Type: -

Identifier Source: org_study_id