Health Condition 1: R251- Tremor, unspecified
Conditions
Interventions
Intervention1: Oral vitamin B12: 1000 microgram oral vitamin B12
(cyanocobalamine) daily for 2 months
Control Intervention1: Intramuscular vitamin B12: Intramuscular vitamin B12(cyanocobalamin)
1000 m
Sponsors
Government Medical College and Hospital Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Children of age group between 3 months and 3 years presenting with features of ITS namely, pallor, developmental delay/regression, skin hyper pigmentation, tremors & brown scanty scalp hair and one of the following Serum vitamin B12 levels below 350 pg/ml or Holotranscobalamin levels below 35 pmol/l will be included in study.27,28 Presence of tremors is not an essential criteria as it is not seen in pre ITS stage of ITS.
Exclusion criteria
Exclusion criteria: 1. Children of parents who decline to give consent for inclusion in the study. 2. Children who have already received Vitamin B12. 3. Children who are already taking micronutrient supplementation. 4. Children who are having normal Vitamin B12 levels on admission (defined as levels above 350 pg/ml).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in serum vitamin B12 levels after one month and two months of therapy from baseline levels in both oral and intramuscular groups.Timepoint: after one month and two months of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in hemogram like improvement in haemoglobin and MCV after one month and two months of therapy from baseline levels in both oral and intramuscular groups.Timepoint: after one month and two months of therapy;Clinical improvement in form of gain of lost appetite, improvement in general activity, gain of lost milestones or gain of delayed milestones, tremors resolution and improved interest in surroundings.Timepoint: at end of therapy;Difference in serum homocysteine levels after one month and two months of therapy from baseline levels in both oral and intramuscular groups.Timepoint: after one month and two months of therapy;Differnce in holotranscobalamin levels after one month and two months of therapy from baseline levels in both oral and intramuscular groupsTimepoint: after one month and two months of therapy | — |
Countries
India
Contacts
Public ContactGeetanjali Jindal
Government Medical College and Hospital, Chandigarh
Outcome results
None listed