The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

Early Phase 1

Recruiting

• Conditions: Drug Resistant Epilepsy
• Interventions: Other: Placebo; Drug: Cholecalciferol

• Registration Number: NCT06053281
• Lead Sponsor: DINA KEUMALA SARI

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 :

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)

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-25
• Study Start: 2024-01-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	DRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks.
Vitamin D	Cholecalciferol	DRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage change of seizure frequency	12 and 24 weeks	Change on number of seizure

Secondary Outcome Measures

Name	Time	Method
Effect on Global Assessment of the Severity of Epilepsy (GASE)	12 and 24 weeks	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)	12 and 24 weeks	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
Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment	12 and 24 weeks	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 Interleukin-1ß levels and seizure frequency change after vitamin D treatment	12 and 24 weeks	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, %)
Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)	12 and 24 weeks	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.
Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment	12 and 24 weeks	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, %)
Responder rate	12 and 24 weeks	Percentage of patients change at least 50% of the seizure frequency
Remission rate after vitamin D treatment	12 and 24 weeks	Percentage of patients without any seizure (seizure freedom)
Effect of vitamin D according to epilepsy type	12 and 24 weeks	Responder rate in focal and generalized epilepsy

Trial Locations

Locations (1)

Faculty of Medicine Universitas Sumatera Utara; 🇮🇩 Medan, North Sumatra, Indonesia