The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

Sponsor

DINA KEUMALA SARI (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06053281

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the incident of epilepsy still very high in Indonesia , thus many patients become drug resistant epilepsy . As vitamin D has some anticonvulsant effect , we want to study if an additional dose of vitamin D can help with the therapy responses.

Condition or Disease	Intervention/Treatment	Phase
Drug Resistant Epilepsy	Drug: Cholecalciferol Other: placebo	Early Phase 1

Detailed Description

specifically we want to study about :

Relationship between serum vitamin D levels and seizure frequency reduction after vitamin D treatment
Relationship between serum GDNF levels and seizure frequency reduction after vitamin D treatment
Relationship between serum Interleukin-1ß levels and seizure frequency reduction after vitamin D treatment
Responder rate. Percentage of patients having a reduction 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

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blinddouble blind

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental arms DRE patients with proved Vitamin D deficiency (Serum vitamin D level <30ng/ml). intervention : Daily Cholecalciferol 1000 IU in 6 months.	Drug: Cholecalciferol Daily Cholecalciferol 1000 IU in 6 months Other Names: Vitamin D
Placebo Comparator: control arms DRE patients with proved Vitamin D deficiency (Serum vitamin D level <30ng/ml). Interventions : Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 6 months.	Other: placebo placebo

Arm

Intervention/Treatment

Experimental: experimental arms

DRE patients with proved Vitamin D deficiency (Serum vitamin D level <30ng/ml). intervention : Daily Cholecalciferol 1000 IU in 6 months.

Drug: Cholecalciferol

Daily Cholecalciferol 1000 IU in 6 months

Other Names:

Vitamin D

Placebo Comparator: control arms

DRE patients with proved Vitamin D deficiency (Serum vitamin D level <30ng/ml). Interventions : Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 6 months.

Other: placebo

placebo

Outcome Measures

Primary Outcome Measures

Percentage change of seizure frequency [3 and 6 months]
Reduction on number of seizure

Secondary Outcome Measures

Relationship between serum vitamin D levels and seizure frequency change after vitamin D treatment [3 and 6 months]
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, %)
Relationship between serum GDNF levels and seizure frequency change after vitamin D treatment [3 and 6 months]
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, %)
Relationship between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment [3 and 6 months]
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, %)
Responder rate [3 and 6 months]
Percentage of patients change at least 50% of the seizure frequency
Remission rate after Vitamin D treatment [3 and 6 months]
Percentage of patients without any seizure (seizure freedom)
Effect of Vitamin D according to epilepsy type [3 and 6 months]
Responder rate in focal and generalized epilepsy
Effect on Global Assessment of the Severity of Epilepsy (GASE) [3 and 6 months]
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.
Effect on Hague Seizure Severity scale (HASS) [3 and 6 months]
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
Effect on Quality of Life in Epilepsy in Children: (QOLCE 55) [3 and 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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