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The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

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ClinicalTrials.gov Identifier: NCT06053281
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : February 14, 2024
Sponsor:
Information provided by (Responsible Party):
DINA KEUMALA SARI, Universitas Sumatera Utara

Study Description
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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.

Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Drug: Cholecalciferol Other: Placebo Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double 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
Actual Study Start Date : January 19, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin D
DRE patients with proved vitamin D deficiency (Serum vitamin D level <30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks.
 Drug: Cholecalciferol
Daily Cholecalciferol 1000 IU in 24 weeks
Other Name: Vitamin D
Placebo Comparator: 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.
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change of seizure frequency [ Time Frame: 12 and 24 weeks ]
    Change on number of seizure


Secondary Outcome Measures :
  1. Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment [ Time Frame: 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, %)

  2. Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment [ Time Frame: 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, %)

  3. Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment [ Time Frame: 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, %)

  4. Responder rate [ Time Frame: 12 and 24 weeks ]
    Percentage of patients change at least 50% of the seizure frequency

  5. Remission rate after vitamin D treatment [ Time Frame: 12 and 24 weeks ]
    Percentage of patients without any seizure (seizure freedom)

  6. Effect of vitamin D according to epilepsy type [ Time Frame: 12 and 24 weeks ]
    Responder rate in focal and generalized epilepsy

  7. Effect on Global Assessment of the Severity of Epilepsy (GASE) [ Time Frame: 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.

  8. Effect on Hague Seizure Severity scale (HASS) [ Time Frame: 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

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


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053281


Contacts
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Contact: Johannes H. Saing 628116333784 jhsaing@usu.ac.id

Locations
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Indonesia
Faculty of Medicine Universitas Sumatera Utara Recruiting
Medan, North Sumatra, Indonesia, 20155
Contact: Dina K Sari    081397177693    dina@usu.ac.id   
Sponsors and Collaborators
DINA KEUMALA SARI
Investigators
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Principal Investigator: Dina K. Sari, SpGK(K), Prof.Dr.dr. Universitas Sumatera Utara
More Information
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Responsible Party: DINA KEUMALA SARI, Sponsor-investigator, Universitas Sumatera Utara
ClinicalTrials.gov Identifier: NCT06053281    
Other Study ID Numbers: USU Neuro Pediatric
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: February 14, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by DINA KEUMALA SARI, Universitas Sumatera Utara:
vitamin D
GDNF
interleukin
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vitamin D
 Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents