High dose vs low dose Vitamin D Supplementation in epileptic children taking anti-seizure medication: A Randomised Control Trial

This is a randomised control trial which will be conducted in the Department of Paediatrics at JSS Medical College and Hospital, Mysuru, a tertiary care teaching hospital. The study will be conducted over a period of 12 months after obtaining approval from the institutional ethics committee. The study aims to supplement High dose vs low doses of Vitamin D to children between 1 year to 18 years of age diagnosed with Epilepsy and taking Monotherapy anti-seizure medication and to establish the better dose of Vitamin D to combat the Vitamin D deficiency in epileptic children taking anti-seizure medication. This is a single-centre study with simple random sampling of eligible children presenting to the OPD and in-patient services.

All children fulfilling the inclusion criteria will be enrolled after obtaining written informed consent from parents or guardian. Vitamin D levels, Calcium, Ionised Calcium, Serum Phosphate and Alkaline Phosphatase will be taken during the first visit. If baseline Vitamin D levels are low, they will be treated with Vitamin D sachets according to Stoss Therapy, 60,000 IU/week for 6 weeks. Repeat Vitamin D testing will be done at the end of 6 weeks. If the Vitamin D levels are normal they will be included in the study. The children will be randomised into high-dose (2000IU/day) and low-dose groups(600IU/day) for a period of six months. They will then be supplemented with oral Vitamin D according to their group. If baseline Vitamin D levels are low, they will be treated with Vitamin D sachets according to Stoss Therapy, 60,000 IU/week for 6 weeks. Repeat Vitamin D testing will be done at the end of 6 weeks. If the Vitamin D levels are normal they will be included in the study.  Repeat tests for Vitamin D, Calcium, Ionised Calcium, Serum Phosphate and Alkaline Phosphatase will be taken after 6 months. The values will be recorded, compared after six months and analysed to find the prevalence of Vitamin D deficiency, bone health and breakthrough seizures in both groups.