The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

Drug Resistant Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053281
• Other study ID #: USU Neuro Pediatric
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 19, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: Universitas Sumatera Utara
• Contact: Johannes H. Saing
• Phone: 628116333784
• Email: jhsaing[@]usu.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

Specifically the investigators want to study about :

1. Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment

2. Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment

3. Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment

4. Responder rate. Percentage of patients change of at least 50% of the seizure frequency

5. Remission rate after vitamin D treatment. Percentage of patients without any seizure (seizure freedom)

6. Effect of vitamin D according to epilepsy type. Responder rate in focal and generalized epilepsy.

7. Effect on Global Assesment of the Severity of Epilepsy (GASE)

8. Effect on Hague Seizure Severity scale (HASS)

9. Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

1. Age 1 - 18 years

2. Drug-resistant epilepsy

3. Having at least 6 unprovoked seizures in the previous 3 months

4. No vitamin D treatment in the previous 6 months

5. Medication compliance

6. Agreeing to participate in the study

7. Having a social insurance

8. Parental agreement

Exclusion Criteria:

1. Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin)

2. Known hypersensitivity to vitamin D

3. Lost to follow up

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Drug:
• Cholecalciferol
Daily Cholecalciferol 1000 IU in 24 weeks

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine Universitas Sumatera Utara	Medan	North Sumatra

Sponsors (1)

Lead Sponsor	Collaborator
DINA KEUMALA SARI

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change of seizure frequency	Change on number of seizure	12 and 24 weeks
Secondary	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, %)	12 and 24 weeks
Secondary	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, %)	12 and 24 weeks
Secondary	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, %)	12 and 24 weeks
Secondary	Responder rate	Percentage of patients change at least 50% of the seizure frequency	12 and 24 weeks
Secondary	Remission rate after vitamin D treatment	Percentage of patients without any seizure (seizure freedom)	12 and 24 weeks
Secondary	Effect of vitamin D according to epilepsy type	Responder rate in focal and generalized epilepsy	12 and 24 weeks
Secondary	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.	12 and 24 weeks
Secondary	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	12 and 24 weeks
Secondary	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.	12 and 24 weeks