The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Phase
Not applicable
Started
2026-06
Last updated
2026-06-16
Condition(s) studied
EpilepsyPregnant WomanBone Health
Investigational drug(s) / intervention(s)
Supplementation with calcium + vitamin D daily.
Supplementation with calcium + vitamin D daily.: 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.
Study 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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Bone metabolisms indicators in offspring — Childbirth 25-hydroxy Vitamin D (ng/ml)，procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)
Bone metabolisms indicators in offspring — Childbirth Parathyroid hormone (PTH, ng/L)
Bone metabolisms indicators in offspring — Childbirth β-crosslaps (β-CTX, pg/ml)
Bone metabolisms indicators in offspring — Childbirth Body length(cm)
Bone metabolisms indicators in offspring — Childbirth Weight(g)
Bone metabolisms indicators in offspring — Childbirth Head circumference(cm)
Trial sites (1)
Facility
City
Region
Status
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang
China
Recruiting
More The Fourth Affiliated Hospital of Zhejiang University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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