Preventing Preeclampsia Recurrence in High-Risk Pregnancies Using Vitamin D Therapy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Recurrence of Preeclampsia
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Vitamin D Supplementation
Participants randomized to this arm will receive oral vitamin D
Intervention: Vitamin D (Cholecalciferol ) (Drug)
Placebo
Participants randomized to this arm will receive a matching placebo with the same taste, color, and consistency as the active treatment
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Recurrence of Preeclampsia
Time Frame: From randomization until 36 weeks of gestation
Recurrence of preeclampsia will be defined as the development of new-onset hypertension (blood pressure ≥140/90 mmHg) and proteinuria (≥1+ on urine dipstick) at 20 weeks of gestation or later in women with a previous history of preeclampsia. Participants with elevated blood pressure will undergo urine protein testing to confirm the diagnosis.
Secondary Outcomes
No secondary outcomes reported
Investigators
Soophiya Khan
Principal Investigator
CMH Multan Institute of Medical Sciences