Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
Intervention1: Vitamin B12: Arm A: Oral vitamin B12 group Each participant will receive once daily 1000 mcg (1 mg) of oral vitamin B12 (hydroxycobalamin), liquid syrup formulation (5 ml/500 mcg) 2ml o
Sponsors
All India Institute of Medical Sciences, Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 6 months to 2 years 2. Confirmed diagnosis of ITS
Exclusion criteria
Exclusion criteria: 1.Parents not consenting for participation in the trial 2. Previously documented allergy to vitamin B12 3. Severe illness requiring PICU admission/Mechanical ventilation 4. Children who have received oral or injectable vitamin B12 within 1 month prior to admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be Assessment of ITS severity score, development quotient and caregiver assessment of tremor severity by Likert scale as compared to baseline in both groupsTimepoint: 1 weeek, 2 weeks, 8 weeks, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor DQ Mental DQ Full- scale DQ Caregiver assessment of tremor severity by Likert scale in both groups Serum B12 level, Hb level MCV, TLC, total platelets count Serum Homocysteine level Timepoint: 2 weeks | — |
Countries
India
Contacts
Public ContactDr Indar Kumar Sharawat
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed