Bone Management in Pregnancy Outcomes in Epilepsy

Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Bone Health; Pregnant Woman
• Intervention / Treatment: Drug: Supplementation with calcium + vitamin D daily.

Detailed Description

Epilepsy, a common neurological disorder, affects approximately over 70 million individuals worldwide and 0.5-1% of women of childbearing age. Management of women with epilepsy (WWE) during their pregnancy period presents significant challenges. Optimal bone metabolism management is an essential component of obstetric care. 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. Based on the vitamin D levels of pregnant women with epilepsy during the early stage of pregnancy, intervention measures were taken to supplement vitamin D. The bone metabolism indicators of the offspring were tested.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiajia Fang; Phone Number: 15215880868; Email: fangjjiaj@zju.edu.cn

Study Locations

• China
  • Zhejiang, China
    • Recruiting
    • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
    • Contact: Jiajia Fang; Phone Number: 15215880868; Email: fangjjiaj@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: calcium + vitamin D group; Intervention for epilepsy patients	Drug: 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.
No Intervention: standard of care group; Epilepsy patients receive normal follow-up without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone metabolisms indicators in offspring	25-hydroxy Vitamin D (ng/ml)，procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)	Childbirth
Bone metabolisms indicators in offspring	Parathyroid hormone (PTH, ng/L)	Childbirth
Bone metabolisms indicators in offspring	β-crosslaps (β-CTX, pg/ml)	Childbirth
Bone metabolisms indicators in offspring	Body length(cm)	Childbirth
Bone metabolisms indicators in offspring	Weight(g)	Childbirth
Bone metabolisms indicators in offspring	Head circumference(cm)	Childbirth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The outcome will be assessed at two critical time points:At Birth (Day 0-7 Post-Delivery)，Within 30 Days Postnatal
Maternal Bone metabolisms indicators	25-hydroxy Vitamin D (ng/ml)，procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)	12, 24, and 36 weeks of pregnancy, the time during delivery
Maternal Bone metabolisms indicators	β-crosslaps (β-CTX, pg/ml)	12, 24, and 36 weeks of pregnancy, the time during delivery
Maternal Bone metabolisms indicators	Parathyroid hormone (PTH,ng/L)	12, 24, and 36 weeks of pregnancy, the time during delivery

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: epilepsy; pregnancy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Biological Factors; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Inorganic Chemicals; Elements; Metals; Blood Coagulation Factors; Metals, Alkaline Earth; Calcium; Dietary Supplements
• Other Study ID Numbers: KY-2022-051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No