Bone Management in Pregnancy Outcomes in Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Supplementation with calcium + vitamin D daily.
DrugTest 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: calcium + vitamin D groupExperimental treatment 1 intervention
Group B: standard of care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Bone metabolisms indicators in offspring
25-hydroxy Vitamin D (ng/ml)，procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)
Time frame
Childbirth2
Bone metabolisms indicators in offspring
Parathyroid hormone (PTH, ng/L)
Time frame
Childbirth3
Bone metabolisms indicators in offspring
β-crosslaps (β-CTX, pg/ml)
Time frame
Childbirth4
Bone metabolisms indicators in offspring
Body length(cm)
Time frame
ChildbirthSecondary outcomes
1
Live birth rate without major congenital malformations (MCMs)
Live Birth Definition: Delivery of a fetus showing any sign of life at ≥20 weeks of gestation (WHO criteria). Major Congenital Malformations (MCMs) definition: Structural or functional abnormalities present at birth (modified from EUROCAT criteria).
Time frame
The outcome will be assessed at two critical time points:At Birth (Day 0-7 Post-Delivery)，Within 30 Days Postnatal2
Maternal Bone metabolisms indicators
25-hydroxy Vitamin D (ng/ml)，procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)
Time frame
12, 24, and 36 weeks of pregnancy, the time during delivery3
Maternal Bone metabolisms indicators
β-crosslaps (β-CTX, pg/ml)
Time frame
12, 24, and 36 weeks of pregnancy, the time during delivery4
Maternal Bone metabolisms indicators
Parathyroid hormone (PTH,ng/L)
Time frame
12, 24, and 36 weeks of pregnancy, the time during deliverySponsors and contacts
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Source ClinicalTrials.gov