Vitamin D to prevent recurrent pre-eclampsia in pregnant women
Role of Vitamin D in Prevention of Preeclampsia Recurrence in Pregnant Women With Previous History of Preeclampsia: A Randomized Controlled Trial
This study will test whether taking 4,000 IU of vitamin D during pregnancy lowers the chance of pre-eclampsia returning in women who had it in a prior pregnancy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Nishtar Medical University Academic / other |
| Locations | 1 site (Multan, Punjab Province) |
| Trial ID | NCT07288801 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 4 trial enrolls pregnant women with a history of pre-eclampsia at the antenatal clinic of Nishtar Medical University and Hospital in Multan. Participants are randomized to receive either 4,000 IU oral vitamin D daily or a matching placebo until 36 weeks' gestation, alongside standard antenatal care. Women attend clinic visits every two weeks for blood pressure checks, and urine protein testing is performed if blood pressure reaches 140/90 mmHg or higher. The trial compares rates of recurrent pre-eclampsia between groups to see if supplementation reduces recurrence.
Who should consider this trial
Good fit: Pregnant women at or beyond 20 weeks' gestation with a documented history of pre-eclampsia who can attend biweekly visits at Nishtar Hospital and do not have excluded comorbidities are ideal candidates.
Not a fit: Women with pre-existing hypertension, significant cardiac or renal disease, thyrotoxicosis, or those presenting with intrauterine fetal death are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could reduce the recurrence of pre-eclampsia and lower related risks to mothers and babies by using an inexpensive, widely available supplement.
How similar studies have performed: Observational studies have linked low vitamin D to higher pre-eclampsia risk, but randomized trials to date have shown mixed and inconclusive results regarding prevention of recurrence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Multan, Punjab Province
- Nishtar Medical University and Hospital — Multan, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Tehseen A Principal Investigator, MBBS
- Email: tehseenaslam451@gmail.com
- Phone: +92 303 7832417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.