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Completed
NCT07717931
Vitamin D Therapy to Prevent Recurrent Preeclampsia in High-Risk Pregnancies
Conditions: Preeclampsia
Sex: Female
Ages: 20 Years – 45 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 146
Sponsor: CMH Multan Institute of Medical Sciences
Location: CMH Multan Institute of Medical Sciences Multan Punjab Province
Summary
The goal of this clinical trial is to determine whether vitamin D supplementation can reduce the recurrence of preeclampsia in pregnant women with a previous history of preeclampsia.
The main questions the study aims to answer are:
\- Does daily vitamin D supplementation reduce the recurrence of preeclampsia compared with a placebo?
Researchers will randomly assign 146 eligible pregnant women to receive either vitamin D supplements or a placebo. The two groups will be compared to determine whether vitamin D lowers the risk of recurrent preeclampsia.
Participants will:
* Be randomly assigned to receive either 4000 IU oral vitamin D once daily or a matching placebo.
* Take the assigned study medication daily until 36 weeks of gestation.
* Attend follow-up visits every 2 weeks for blood pressure measurement and clinical assessment.
* Have serum vitamin D levels measured every 4 weeks to monitor for vitamin D toxicity.
* Undergo urine testing for protein if blood pressure is elevated to assess for preeclampsia.
The results of this study will help determine whether vitamin D supplementation is an effective and safe strategy for preventing recurrent preeclampsia in women at high risk.
Eligibility Criteria
Inclusion Criteria:
* Pregnant women
* Singleton pregnancy (on USG)
* Gestational age ≥ 24-weeks (on LMP method) and
* Past medical history of pre-eclampsia (on medical record)
Exclusion Criteria:
* Pre-existing chronic hypertension
* Cardiac diseases (congenital or acquired)
* Renal disease
* Thyrotoxicosis (on history and medical record) and
* Intra-uterine death of the fetus.
Source: ClinicalTrials.gov (NCT07717931). StuddyBuddy aggregates publicly available trial information.