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NCT Number: NCT07651709

Bone Management in Pregnancy Outcomes in Epilepsy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, China

Location status: Recruiting

Location contact

Jiajia Fang

CONTACT

[email protected]

15215880868

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplementation with calcium + vitamin D daily.

Drug

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.

Primary outcomes

  1. Bone metabolisms indicators in offspring

    Time frame: Childbirth

    25-hydroxy Vitamin D (ng/ml),procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)

  2. Bone metabolisms indicators in offspring

    Time frame: Childbirth

    Parathyroid hormone (PTH, ng/L)

  3. Bone metabolisms indicators in offspring

    Time frame: Childbirth

    β-crosslaps (β-CTX, pg/ml)

  4. Bone metabolisms indicators in offspring

    Time frame: Childbirth

    Body length(cm)

  5. Bone metabolisms indicators in offspring

    Time frame: Childbirth

    Weight(g)

  6. Bone metabolisms indicators in offspring

    Time frame: Childbirth

    Head circumference(cm)

Secondary outcomes

  1. Live birth rate without major congenital malformations (MCMs)

    Time frame: The outcome will be assessed at two critical time points:At Birth (Day 0-7 Post-Delivery),Within 30 Days Postnatal

    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).

  2. Maternal Bone metabolisms indicators

    Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery

    25-hydroxy Vitamin D (ng/ml),procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)

  3. Maternal Bone metabolisms indicators

    Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery

    β-crosslaps (β-CTX, pg/ml)

  4. Maternal Bone metabolisms indicators

    Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery

    Parathyroid hormone (PTH,ng/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia Fang

CONTACT

[email protected]

15215880868

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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