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临床试验/NCT06053281
NCT06053281招募中早期 1 期

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

DINA KEUMALA SARI1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月19日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Percentage change of seizure frequency
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
1 Year 至 18 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Vitamin D

Experimental

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

干预措施: Cholecalciferol (Drug)

Placebo

Placebo Comparator

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

干预措施: Placebo (Other)

结局指标

主要结局

Percentage change of seizure frequency

时间窗: 12 and 24 weeks

Change on number of seizure

次要结局

  • Effect on Global Assessment of the Severity of Epilepsy (GASE)(12 and 24 weeks)
  • Effect on Hague Seizure Severity scale (HASS)(12 and 24 weeks)
  • Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment(12 and 24 weeks)
  • Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment(12 and 24 weeks)
  • Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)(12 and 24 weeks)
  • Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment(12 and 24 weeks)
  • Responder rate(12 and 24 weeks)
  • Remission rate after vitamin D treatment(12 and 24 weeks)
  • Effect of vitamin D according to epilepsy type(12 and 24 weeks)

研究者

发起方
DINA KEUMALA SARI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

DINA KEUMALA SARI

Sponsor-investigator

Universitas Sumatera Utara

研究点 (1)

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