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The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

Primary Purpose

Drug Resistant Epilepsy

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
DINA KEUMALA SARI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring vitamin D, GDNF, interleukin

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Medicine Universitas Sumatera Utara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks.

DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks.

Outcomes

Primary Outcome Measures

Percentage change of seizure frequency
Change on number of seizure

Secondary Outcome Measures

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, %)
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, %)
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, %)
Responder rate
Percentage of patients change 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 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.
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
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.

Full Information

First Posted
August 29, 2023
Last Updated
September 29, 2023
Sponsor
DINA KEUMALA SARI
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1. Study Identification

Unique Protocol Identification Number
NCT06053281
Brief Title
The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
DINA KEUMALA SARI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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, 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy
Keywords
vitamin D, GDNF, interleukin

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double blind
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D
Intervention Description
Daily Cholecalciferol 1000 IU in 24 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage change of seizure frequency
Description
Change on number of seizure
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
Description
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, %)
Time Frame
12 and 24 weeks
Title
Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
Description
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, %)
Time Frame
12 and 24 weeks
Title
Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
Description
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, %)
Time Frame
12 and 24 weeks
Title
Responder rate
Description
Percentage of patients change at least 50% of the seizure frequency
Time Frame
12 and 24 weeks
Title
Remission rate after vitamin D treatment
Description
Percentage of patients without any seizure (seizure freedom)
Time Frame
12 and 24 weeks
Title
Effect of vitamin D according to epilepsy type
Description
Responder rate in focal and generalized epilepsy
Time Frame
12 and 24 weeks
Title
Effect on Global Assessment of the Severity of Epilepsy (GASE)
Description
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.
Time Frame
12 and 24 weeks
Title
Effect on Hague Seizure Severity scale (HASS)
Description
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
Time Frame
12 and 24 weeks
Title
Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)
Description
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.
Time Frame
12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes H. Saing
Phone
628116333784
Email
jhsaing@usu.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina K. Sari, SpGK(K), Prof.Dr.dr.
Organizational Affiliation
Universitas Sumatera Utara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Universitas Sumatera Utara
City
Medan
State/Province
North Sumatra
ZIP/Postal Code
20155
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

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