Bone Management in Pregnancy Outcomes in Epilepsy
Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
80 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
Summary
This study is aimed to evaluate the efficacy of bone health management in improving pregnancy outcomes among WWE, and establish evidence-based vitamin D supplementation strategies for childbearing-age WWE.
Eligibility
Inclusion Criteria3
- Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy.
- Women of childbearing age, aged ≥18 years, planning pregnancy or in early pregnancy (≤16 weeks gestation, confirmed by last menstrual period or ultrasound) - single pregnancy.
- Willing and able to provide written informed consent.
Exclusion Criteria5
- Pre-existing conditions affecting bone metabolism: primary hyperparathyroidism, Paget's disease, multiple myeloma, chronic kidney disease (eGFR <60 mL/min), cirrhosis (Child-Pugh B/C), or untreated hyper/hypothyroidism.
- History of metabolic complications: hypercalcemia (serum Ca²⁺ >10.5 mg/dL), nephrolithiasis, or granulomatous diseases.
- Recent/current use of bone-modifying drugs: bisphosphonates, glucocorticoids (≥5 mg/day prednisone equivalent for >1 month), or loop diuretics within the past year.
- Ultrasound shows fetal malformation.
- Presence of other severe systemic diseases deemed unsuitable for study participation by the investigator.
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Interventions
Test bone metabolism indicators at 10-14 weeks of pregnancy and intervene based on vitamin D levels. * For vitamin D levels \> 20 ng/ml: Supplementation with 725 mg of calcium + 500 IU of vitamin D daily. * For 10 ng/ml \< vitamin D levels ≤20 ng/ml: Supplementation with 725 mg of calcium + 900 IU of vitamin D daily. * For vitamin D levels ≤10 ng/ml: Supplementation with 725 mg of calcium + 1300 IU of vitamin D daily.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07651709