Health Condition 1: null- Pre-Infantile Tremor Syndrome and Infantile Tremor Syndrome
Conditions
Interventions
Intervention1: Vitamin B12 monotherapy: 1000 mcg of Injection Hydroxocobalamin will be administered once daily intramuscularly in alternate thighs
Control Intervention1: Combination with multinutrient
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 3month to 2 years of either sex meeting the criteria for Infantile Tremor Syndrome 2. Infantile Tremor Syndrome: Developmental delay or regression WITH history of exclusive or predominant breast feeding WITH two or more of the following; skin pigmentation, sparse or lightly pigmented hair, and/or tremors.
Exclusion criteria
Exclusion criteria: 1. Parents not consenting 2. Patients requiring multinutrient therapy: (Severe anemia requiring blood transfusion, Severe acute malnutrition with complications, acute diarrhea, symptomatic hypocalcemia and vitamin D deficiency) 3. Severe illness requiring PICU admission/Mechanical ventilation 4. Children who have received oral or injectable vitamin B12 within 1 month prior to admission 5. Later confirmation of an alternative diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean Likert scores of children treated with daily injectable Vitamin B-12 (1mg) versus injectable Vitamin B-12(1mg) + other multinutrientsTimepoint: One week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in CAPUTE scores between the two arms at one week 2. Mean change in CAPUTE and VSMS scores between the two arms at one monthTimepoint: 1 week and 1 month | — |
Countries
India
Contacts
Public ContactDr Naveen Sankhyan
PGIMER
Outcome results
None listed