Preeclampsia
Conditions
Keywords
Vitamin D, Cholecalciferol, Preeclampsia Recurrence, High-Risk Pregnancy, Pregnancy-Induced Hypertension, Placebo
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.
Interventions
Vitamin D 4000 IU will be administered orally once daily from enrollment until 36 weeks of gestation. They will attend follow-up visits every 2 weeks for blood pressure monitoring and clinical assessment, with serum vitamin D levels measured every 4 weeks.
DRUGPlacebo
A matching placebo with the same taste, color, and consistency as vitamin D will be administered orally once daily from enrollment until 36 weeks of gestation for comparison with vitamin D supplementation.
Sponsors
CMH Multan Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Preeclampsia | 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. |
Countries
Pakistan
Contacts
STUDY_CHAIRNidda Y Assistant Professor, FCPS
CMH Multan Institute of Medical Sciences
Outcome results
None listed