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Bone health boost may help pregnant women with epilepsy

NCT ID NCT07651709

Disease control Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving calcium and vitamin D supplements based on vitamin D levels can improve pregnancy outcomes in women with epilepsy. Researchers will enroll 80 women who are planning pregnancy or are in early pregnancy. Participants will receive different doses of calcium and vitamin D depending on their initial vitamin D levels, and the study will track bone health markers in both mothers and babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
calcium and vitamin D supplements
What this could lead to
If successful, this could establish a simple, evidence-based vitamin D supplementation strategy to improve bone health and pregnancy outcomes in women with epilepsy.
What could go wrong
This is a small, early-stage trial with only 80 participants, so results may not apply widely. The study focuses on bone metabolism markers rather than major clinical outcomes, so the real-world benefit is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone health Epilepsy Pregnant woman

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Zhejiang, China

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