Drug Resistant EpilepsyEarly Phase 1NCT06053281
The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy
A Early Phase 1 study testing Cholecalciferol in people with Drug Resistant Epilepsy, run by DINA KEUMALA SARI at 1 site in Indonesia.
Trial summary
The incident of epilepsy still very high in Indonesia, thus many patients become drug resistant epilepsy. As vitamin D has some anticonvulsant effect, the investigators want to study if an additional dose of vitamin D can help with the therapy responses. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Jan 2024to 1 Jul 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1 - 18 years
- Drug-resistant epilepsy
- Having at least 6 unprovoked seizures in the previous 3 months
- No vitamin D treatment in the previous 6 months
- Medication compliance
- Agreeing to participate in the study
- Having a social insurance
- Parental agreement
Who cannot join
- Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin)
- Known hypersensitivity to vitamin D
- Lost to follow up
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatra, 20155
Dina K Sari, 081397177693, dina@usu.ac.id
About this study
Official title: The Role Of Vitamin D For Therapy Responses On Drug Resistant Epilepsy Through Glial-Cell-Line Derived Neurotrophic Factor (GDNF) And Interleukin 1ß (IL-1 ß) Modulation Pathway
The incident of epilepsy still very high in Indonesia, thus many patients become drug resistant epilepsy. As vitamin D has some anticonvulsant effect, the investigators want to study if an additional dose of vitamin D can help with the therapy responses.
Read the detailed description
Specifically the investigators want to study about :
- Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
- Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
- Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
- Responder rate. Percentage of patients change of at least 50% of the seizure frequency
- Remission rate after vitamin D treatment. Percentage of patients without any seizure (seizure freedom)
- Effect of vitamin D according to epilepsy type. Responder rate in focal and generalized epilepsy.
- Effect on Global Assesment of the Severity of Epilepsy (GASE)
- Effect on Hague Seizure Severity scale (HASS)
- Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)
- Conditions
- Drug Resistant Epilepsy
- Being tested
- Cholecalciferol, Placebo
- Keywords
- vitamin D, GDNF, interleukin
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D
Daily Cholecalciferol 1000 IU in 24 weeks
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks. Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of seizure frequency
Change on number of seizure
Measured: 12 and 24 weeks
Secondary outcomes (9)
Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
The vitamin D levels (in ng/mL) of each participant is measured at the beginning and the end of the study and then the investigators calculate the seizure frequency change (in percentage, %)
Measured: 12 and 24 weeks
Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
The serum GDNF levels (in ng/mL) of each participant is measured at the beginning and the end of the study and then the investigators calculate the seizure frequency change (in percentage, %)
Measured: 12 and 24 weeks
Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
The serum Interleukin-1ß levels (in ng/mL) of each participant is measured at the beginning and the end of the study and then the investigators calculate the seizure frequency change (in percentage, %)
Measured: 12 and 24 weeks
Responder rate
Percentage of patients change at least 50% of the seizure frequency
Measured: 12 and 24 weeks
Remission rate after vitamin D treatment
Percentage of patients without any seizure (seizure freedom)
Measured: 12 and 24 weeks
Effect of vitamin D according to epilepsy type
Responder rate in focal and generalized epilepsy
Measured: 12 and 24 weeks
Effect on Global Assessment of the Severity of Epilepsy (GASE)
Effect on Global Assessment of the Severity of Epilepsy (GASE) will be performed at beginning and the end of the study with 7 point Likert in which options are 1 = Not at all severe, 2 = A little severe, 3 = Somewhat severe, 4 = Moderately severe, 5 = Quite severe, 6 = Very severe, 7 = Extremely severe.
Measured: 12 and 24 weeks
Effect on Hague Seizure Severity scale (HASS)
The Hague Seizure Severity scale (HASS) will be performed at beginning and the end of the study with minimum score = 13 to maximum score = 54, in which the lower score indicates the lowest level of seizure severity
Measured: 12 and 24 weeks
Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)
Effect on Quality of Life in Epilepsy in Children: (QOLCE 55) will be performed at beginning and the end of the study with 5 points in which options are 1 = Poor, 2 = Fair, 3 = Good, 4 = Very good, 5 = Excellent.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start19 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DINA KEUMALA SARI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DINA KEUMALA SARI, Universitas Sumatera Utara
- Investigators
- Dina K. Sari, SpGK(K), Prof.Dr.dr., Principal investigator, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053281
- Sponsor's protocol ID
- USU Neuro Pediatric
- Status last verified
- Feb 2024
- First submitted
- 29 Aug 2023
- Last updated
- 14 Feb 2024
- 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 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Vitamin D For Therapy Responses On Drug Resistant Epilepsy Through Glial-Cell-Line Derived Neurotrophic Factor (GDNF) And Interleukin 1ß (IL-1 ß) Modulation Pathway
- ClinicalTrials.gov ID
- NCT06053281
- Acronym / sponsor ID
- USU Neuro Pediatric
- Conditions
- Drug Resistant Epilepsy
- Keywords
- vitamin D, GDNF, interleukin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- DINA KEUMALA SARIUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 25 Sep 2023 (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.
The incident of epilepsy still very high in Indonesia, thus many patients become drug resistant epilepsy. As vitamin D has some anticonvulsant effect, the investigators want to study if an additional dose of vitamin D can help with the therapy responses.
Detailed description
Specifically the investigators want to study about :
- Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
- Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
- Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
- Responder rate. Percentage of patients change of at least 50% of the seizure frequency
- Remission rate after vitamin D treatment. Percentage of patients without any seizure (seizure freedom)
- Effect of vitamin D according to epilepsy type. Responder rate in focal and generalized epilepsy.
- Effect on Global Assesment of the Severity of Epilepsy (GASE)
- Effect on Hague Seizure Severity scale (HASS)
- Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: CholecalciferolDRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks. |
| Placebo | Placebo comparator | Other: PlaceboDRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 1 - 18 years
- Drug-resistant epilepsy
- Having at least 6 unprovoked seizures in the previous 3 months
- No vitamin D treatment in the previous 6 months
- Medication compliance
Key exclusion criteria (3 listed)
- Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin)
- Known hypersensitivity to vitamin D
- Lost to follow up
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin DDaily Cholecalciferol 1000 IU in 24 weeks | Drug | Vitamin D |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Percentage change of seizure frequency
Time frame: 12 and 24 weeks
Change on number of seizure
9 secondary outcomes
Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
Time frame: 12 and 24 weeks
Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
Time frame: 12 and 24 weeks
Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
Time frame: 12 and 24 weeks
Responder rate
Time frame: 12 and 24 weeks
Remission rate after vitamin D treatment
Time frame: 12 and 24 weeks
Effect of vitamin D according to epilepsy type
Time frame: 12 and 24 weeks
Effect on Global Assessment of the Severity of Epilepsy (GASE)
Time frame: 12 and 24 weeks
Effect on Hague Seizure Severity scale (HASS)
Time frame: 12 and 24 weeks
Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)
Time frame: 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- 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. This study is not recruiting at the moment.
Dina K. Sari, SpGK(K), Prof.Dr.dr. principal investigator
Universitas Sumatera Utara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cholecalciferol in people with Drug Resistant Epilepsy, run by DINA KEUMALA SARI at 1 site in Indonesia.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. 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 Indonesia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes H. Saing (628116333784, jhsaing@usu.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of seizure frequency (time frame: 12 and 24 weeks). 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 14 Feb 2024.