Health Condition 1: PCS-
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Dr Varsha Patil R
Eligibility
Inclusion criteria
Inclusion criteria: Infants and children aged 6 months to 5 years who are admitted to the NRC with severe acute malnutrition with vitamin B12 deficiency
Exclusion criteria
Exclusion criteria: (1)Hemoglobin lessthan 5 gper dL requiring urgent transfusion (2)Children with SAM who have acute life threatening complications requiring ICU care, (3)Those with known disorders of B12 absorption or metabolism (e.g. short gut, congenital B12 malabsorption), (4)Those who received vitamin B12 injection per oral in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical vitamin B12 correction at8 days, defined as serum vitamin B 12 morethan 200 pg per mLTimepoint: Biochemical vitamin B12 correction at8 days, defined as serum vitamin B 12 morethan 200 pg per mL | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin improvement ii) MUAC gain: Continuous outcome change in mid-upper arm circumference (in cm) from baseline to week 2. We will also assess the average weekly MUAC increment and the proportion of children who achieve MUAC more than 11.5 cm (threshold for exiting SAM) by 4 weeks. iii) Neurological recovery: This is a composite, qualitative outcome. We will use clinical criteria such as improvement in muscle tone (e.g. from hypotonia to normal tone), alertness and activity, and developmental progress. Adverse events: All adverse events will be documented and classified by severity and relation to intervention. Key outcomes will be the occurrence of any injection site complications (like swelling, abscess, nerve injury symptoms) in the IM group versus any IV infusion complications (phlebitis, extravasation) in the IV groupTimepoint: Hemoglobin improvement ii) MUAC gain: Continuous outcome change in mid-upper arm circumference (in cm) from baseline to week 2. We will also assess the average weekly MUAC increment and the proportion of children who achieve MUAC more than11.5 cm (threshold for exiting SAM) by 4 weeks. iii) Neurological recovery: This is a composite, qualitative outcome. We will use clinical criteria such as improvement in muscle tone (e.g. from hypotonia to normal tone), alertness and activity, and developmental progress. Adverse events: All adverse events will be documented and classified by severity and relation to intervention. Key outcomes will be the occurrence of any injection site complications (like swelling, abscess, nerve injury symptoms) in the IM group versus any IV infusion complications (phlebitis, extravasation) in the IV group | — |
Countries
India
Contacts
Public ContactDr Varsha Patil R
KMCRI , HUBBALLI
Outcome results
None listed