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Recruiting NCT07288801

Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women

Phase IV Interventional Pre-eclampsia Pregnancy Vitamin D

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D, Placebo and standard of care.
Who it may be relevant to
Registry conditions: Pre-eclampsia, Pregnancy, Vitamin D. Basic parameters: 20 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Role of Vitamin D in Prevention of Preeclampsia Recurrence in Pregnant Women With Previous History of Preeclampsia: A Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Vitamin D
    4000 IU of vitamin D will be given orally, once daily till 36-weeks of gestation
  • Drug Placebo and standard of care
    Look, smell and taste alike oil emulsion drops, same number, till 36-weeks of gestation

Primary outcome measures

  • Pre-eclampsia [Time frame: From enrollment till 36 completed weeks of gestation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Pakistan · 1 center
  • Nishtar Medical University and Hospital — Multan

Identifiers

NCT: NCT07288801 · U1111-1332-4347

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗