Comparison of efficacy and safety of oral versus intramuscular vitamin B12 in children with infantile tremor syndrome: a randomized-controlled trial

Infantile Tremor Syndrome is a neuroregressive disorder linked to vitamin B12 deficiency in infants and young children. Although intramuscular vitamin B12 is the current standard of care, its painful administration, poor compliance, and limited feasibility in low resource settings necessitate the evaluation of an effective and more acceptable oral alternative. This randomized controlled trial aims to compare the efficacy and safety of oral versus intramuscular vitamin B12 supplementation in the treatment of children with Infantile Tremor Syndrome. The study will include children aged six months to two years with a confirmed diagnosis of Infantile Tremor Syndrome. Participants will be randomly allocated in a one to one ratio into two groups using block randomization. Group one will receive oral vitamin B12 and group two will receive intramuscular vitamin B12. The primary outcome will be the change in tremor severity score at two weeks compared to baseline. Secondary outcomes will include changes in serum vitamin B12, homocysteine, hemoglobin, mean corpuscular volume, leukocyte and platelet counts, developmental quotient, caregiver impression of tremor severity, and frequency of treatment emergent adverse effects. The study will be conducted at the Pediatric Neurology Division, Department of Pediatrics, AIIMS Rishikesh, over a duration of twenty four months. Data will be collected using a structured proforma and analyzed using SPSS version 26.0. The results are expected to determine whether oral vitamin B12 is as effective and safe as intramuscular vitamin B12, potentially offering a simpler and patient friendly treatment option for Infantile Tremor Syndrome in resource constrained settings.