Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women
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 →
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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