Bone health and vitamin D for pregnant women with epilepsy
Official title: Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study
Run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT07651709 · Data updated 2026-11-12
We’re testing whether giving calcium and vitamin D to women with epilepsy who are trying to become or are early in pregnancy helps pregnancy outcomes and bone health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Zhejiang) |
| Status | Recruiting |
| Started | June 2026 |
| Main results expected | January 2035 |
| Study ends | January 2035 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT07651709 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with epilepsy who are planning pregnancy or are in early pregnancy (≤16 weeks), aged 18 or older, and without exclusionary bone or systemic conditions.
✕Probably not a fit
Women with conditions or histories that are exclusionary (e.g., certain bone disorders, kidney disease, severe systemic diseases) may not benefit from this supplementation strategy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study focuses on pregnant or planning-to-pregnant women with epilepsy to see if daily calcium plus vitamin D improves pregnancy outcomes and supports bone health. Vitamin D levels are used to tailor supplementation, and bone metabolism indicators in offspring are monitored. Participants are adult women with epilepsy, without certain bone-related or systemic exclusion conditions, and the intervention is standard calcium and vitamin D supplementation. The study is conducted at The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Outcomes will inform vitamin D strategies for childbearing-age WWE.
Why it matters
Potential benefit: If successful, the approach could improve pregnancy outcomes and bone health for mothers with epilepsy and their babies.
How similar studies have gone: Similar bone-health interventions have shown promise in related populations, but this specific vitamin D–driven approach in WWE during pregnancy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, China Recruiting
Study contacts
- Study coordinator: Jiajia Fang
- Email: fangjjiaj@zju.edu.cn
- Phone: 15215880868
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.