Effect of vitamin D supplementation in epilepsy

Effect of vitamin D supplementation on seizure frequency in persons with drug resistant epilepsy and its correlation with biomarkers

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029862

Enrollment

190

Registered

2020-12-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Vitamin D3- Cholecalciferol: Patients of vitamin D arm will receive oral vitamin D supplementation for 6 months (vitamin D3- Cholecalciferol 60,000 IU weekly once orally for initial 3 m

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed persons with drug resistant epilepsy (definition as per ILAE) PWE on stable AEDs treatment regimen for at least 3 months Subject having seizure frequency 2 or more per month Subject of age 18 to 70 years of either gender. Subject with serum level of 25 (OH) vitamin D No vitamin D or calcium supplementation in the past 3 months prior to enrolment. Ability to maintain seizure diary

Exclusion criteria

Exclusion criteria: Pregnant or seeking pregnancy, lactating women Associated neurological diseases other than epilepsy Progressive brain diseases Subject undergoing AED tapering Patient on drugs known to alter seizure threshold (e.g. INH, theophylline, metronidazole etc.) Patient on antitubercular drugs or any other drugs known to cause interaction with AEDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole etc.) Treatments influencing the metabolism of vitamin D (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin) Known hypersensitivity to vitamin D Subjects with more than equal to 2 times of normal parathyroid hormone (PTH) level. Subject refused to give informed consent Poor compliance to AEDs

Design outcomes

Secondary

Measure	Time frame
1. To find out percentage of persons with DRE converted to drug responder after six months of vitamin D supplementation with a minimum of 13 months follow-up.Timepoint: 3 years;2. To find out the change in VDR expression and serum 25 (OH) vitamin D among PWE after six months of vitamin D supplementation.Timepoint: 3 years;3. To find out the effect of vitamin D supplementation on epileptogenesis by estimation of various biomarkers involved in the pathways of epileptogenesis such as: a. Neurotransmitter level: Gamma amino butyric acid (GABA) and glutamate b. Inflammatory markers: High mobility group box 1 protein (HMGB 1) c. Neurotrophic markers: Glial cell derived neurotrophic factors (GDNF) d. Oxidative stress: Malondialdehyde (MDA), reduced glutathione (GSH) Timepoint: 3 years;4. To find out the effect of vitamin D supplementation on quality of life, psychiatric and behavioural adverse effects (PBAEs) using validated questionnaires in PWE along with monitoring of adverse drug reactions.Timepoint: 3 years	—

Measure

Time frame

1. To find out percentage of persons with DRE converted to drug responder after six months of vitamin D supplementation with a minimum of 13 months follow-up.Timepoint: 3 years;2. To find out the change in VDR expression and serum 25 (OH) vitamin D among PWE after six months of vitamin D supplementation.Timepoint: 3 years;3. To find out the effect of vitamin D supplementation on epileptogenesis by estimation of various biomarkers involved in the pathways of epileptogenesis such as: a. Neurotransmitter level: Gamma amino butyric acid (GABA) and glutamate b. Inflammatory markers: High mobility group box 1 protein (HMGB 1) c. Neurotrophic markers: Glial cell derived neurotrophic factors (GDNF) d. Oxidative stress: Malondialdehyde (MDA), reduced glutathione (GSH) Timepoint: 3 years;4. To find out the effect of vitamin D supplementation on quality of life, psychiatric and behavioural adverse effects (PBAEs) using validated questionnaires in PWE along with monitoring of adverse drug reactions.Timepoint: 3 years

—

Primary

Measure	Time frame
To find out the percentage change in seizure frequency in persons with drug resistant epilepsy (DRE) after 6 months of vitamin D supplementation as compared to placebo treatment with ongoing AEDs therapyTimepoint: 3 years	—

Countries

India

Contacts

Public ContactProf Manjari Tripathi

All India Institute of Medical Sciences, New Delhi

pattnaiksoumya3@gmail.com8249684127

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026