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Clinical Outcomes and Serum Vitamin D Levels of Empirical versus Stratified Vitamin D2 Supplementation in Patients with Epilepsy: A Non-inferiority Randomized Trial

Clinical Outcomes and Serum Vitamin D Levels of Empirical versus Stratified Vitamin D2 Supplementation in Patients with Epilepsy: A Non-inferiority Randomized Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260507007
Enrollment
120
Registered
2026-05-07
Start date
2026-05-26
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Epilepsy Epilepsy, Vitamin D, Supplementation, Seizure

Interventions

empirical fixed-dose vitamin D2 supplementation (40,000 IU/week),stratified regimen adjusted by 25(OH)D levels
Empirical,Stratified

Sponsors

Prapokklao Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with epilepsy according to ILAE standards. 2. Age: 15 years or older 3. Serum 25(OH)D levels < 40 ng/mL. 4. Maintained on a stable dose of anti-seizure medications (ASMs) for at least 8 weeks prior to enrollment. 5. Ability to accurately maintain a Seizure Diary, either by the patient or with the assistance of a caregiver.

Exclusion criteria

Exclusion criteria: 1. Current Vitamin D Supplementation: Use of any form of vitamin D supplements within 4 weeks prior to the start of the study. 2. Presence of malabsorption, Inflammatory Bowel Disease (IBD), or a history of bariatric surgery. 3. Liver and Kidney Diseases: Chronic Kidney Disease (eGFR less than 30 mL/min/1.73 m2) or Liver Cirrhosis, which affects vitamin D metabolism. 4. Presence of hypercalcemia or a history of recurrent nephrolithiasis (kidney stones). 5. History of heavy drug or alcohol use. 6. Currently pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
The proportion of patients achieving the target serum vitamin D level at 12 weeks after supplementation 25(OH)D level

Secondary

MeasureTime frame
seizure free 12 weeks period during supplementation seizures frequency

Countries

Thailand

Contacts

Public ContactChumpol Anamnart

Prapokklao Hospital

chumpolan@gmail.com0814306100

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026