Abstract
Purpose
Preclinical and early clinical research indicates that Vitamin D3 may reduce seizures
in both animal models and open-label clinical trials.
Methods
This is an initial report of an ongoing pilot study of oral Vitamin D3 5000 IU/day
in subjects with drug-resistant epilepsy. After Institutional Review Board (IRB) approval
and informed consent, subjects with ;less than one focal onset or generalized tonic–clonic
seizure per month were enrolled. Subjects entered a 4-week baseline, followed by a
12-week treatment period. Serum 25, OH Vitamin D3, Blood Urea Nitrogen (BUN), creatinine,
and calcium levels were monitored at baseline and at 6 and 12 weeks.
Results
High-dose Vitamin D3 5000 IU/day was well tolerated. Serum 25, OH Vitamin D3 levels
increased significantly at six and twelve weeks. Vitamin D insufficiency, defined
as a 25, OH Vitamin D3 level of <20 ng/ml normalized in all subjects with insufficient vitamin D levels. Median seizure
frequency declined from 5.18 seizures per month to 3.64 seizures per month at 6 weeks
and to 4.2 seizures per month at 12 weeks. The median percent change in seizure frequency
was −26.9% at six weeks, and −10.7% at 12 weeks (not significant, Wilcoxon Signed Rank Test, P > 0.34).
Conclusions
High-dose oral Vitamin D3, 5000 IU/day was safe and well tolerated in subjects with
epilepsy. Vitamin D levels increased significantly at 6 and 12 weeks but never exceeded
potentially toxic levels, defined as >100 ng/ml. To reduce variability, we will now recruit subjects who only have three
or more seizures per month.
Keywords
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Article info
Publication history
Published online: April 07, 2019
Accepted:
March 3,
2019
Received in revised form:
March 1,
2019
Received:
December 10,
2018
Identification
Copyright
© 2019 Elsevier Inc. All rights reserved.