Bone Management in Pregnancy Outcomes in Epilepsy

Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study ID
NCT07651709
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2035
Completion
Jan 31, 2035

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: calcium + vitamin D group
    Intervention for epilepsy patients
  • No Intervention: standard of care group
    Epilepsy patients receive normal follow-up without any intervention.

Primary Outcome Measure

Bone metabolisms indicators in offspring [ Time Frame: Childbirth ]

Central Contacts

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