Bone Management in Pregnancy Outcomes in Epilepsy
Recruiting · NCT07651709 · Interventional (participants receive a specific treatment) · Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Supplementation with calcium + vitamin D daily.
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine - Zhejiang, China