EpilepsyNCT07651709
Bone Management in Pregnancy Outcomes in Epilepsy
A study testing Supplementation with calcium + vitamin D daily. in people with Epilepsy and Pregnant Woman, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Pregnant Woman, Bone Health
- What is being tested?
- Supplementation with calcium + vitamin D daily.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang
Jiajia Fang, 15215880868, fangjjiaj@zju.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy, Pregnant Woman, Bone Health
- Being tested
- Supplementation with calcium + vitamin D daily.
- Keywords
- epilepsy, pregnancy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| calcium + vitamin D group | Experimental | Intervention for epilepsy patients Receives: Drug: Supplementation with calcium + vitamin D daily. |
| standard of care group | No intervention | Epilepsy patients receive normal follow-up without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone metabolisms indicators in offspring
25-hydroxy Vitamin D (ng/ml)，procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)
Measured: Childbirth
Bone metabolisms indicators in offspring
Parathyroid hormone (PTH, ng/L)
Measured: Childbirth
Bone metabolisms indicators in offspring
β-crosslaps (β-CTX, pg/ml)
Measured: Childbirth
Bone metabolisms indicators in offspring
Body length(cm)
Measured: Childbirth
Bone metabolisms indicators in offspring
Weight(g)
Measured: Childbirth
Bone metabolisms indicators in offspring
Head circumference(cm)
Measured: Childbirth
Secondary outcomes (4)
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).
Measured: 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)
Measured: 12, 24, and 36 weeks of pregnancy, the time during delivery
Maternal Bone metabolisms indicators
β-crosslaps (β-CTX, pg/ml)
Measured: 12, 24, and 36 weeks of pregnancy, the time during delivery
Maternal Bone metabolisms indicators
Parathyroid hormone (PTH,ng/L)
Measured: 12, 24, and 36 weeks of pregnancy, the time during delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJan 2035 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651709
- Sponsor's protocol ID
- KY-2022-051
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study
- ClinicalTrials.gov ID
- NCT07651709
- Acronym / sponsor ID
- KY-2022-051
- Conditions
- Epilepsy, Pregnant Woman, Bone Health
- Keywords
- epilepsy, pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2035 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium + vitamin D group | Experimental | Drug: Supplementation with calcium + vitamin D daily.Intervention for epilepsy patients |
| standard of care group | No intervention | –Epilepsy patients receive normal follow-up without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | calcium + vitamin D group |
Primary outcome
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)
Bone metabolisms indicators in offspring
Time frame: Childbirth
Parathyroid hormone (PTH, ng/L)
Bone metabolisms indicators in offspring
Time frame: Childbirth
β-crosslaps (β-CTX, pg/ml)
Bone metabolisms indicators in offspring
Time frame: Childbirth
Body length(cm)
Bone metabolisms indicators in offspring
Time frame: Childbirth
Weight(g)
Bone metabolisms indicators in offspring
Time frame: Childbirth
Head circumference(cm)
4 secondary outcomes
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
Maternal Bone metabolisms indicators
Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery
Maternal Bone metabolisms indicators
Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery
Maternal Bone metabolisms indicators
Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation with calcium + vitamin D daily. in people with Epilepsy and Pregnant Woman, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiajia Fang (15215880868, fangjjiaj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone metabolisms indicators in offspring (time frame: Childbirth). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.