Oral vs intramuscular administration of vitamin B12 for the treatment of children with vitamin B12 deficiency
- Conditions
- Health Condition 1: E539- Vitamin B deficiency, unspecified
- Registration Number
- CTRI/2023/08/056877
- Lead Sponsor
- o sponsorship
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Children aged 5-14 years
2. Any of the clinical features with suspected megaloblastic anemia like pallor, hyperpigmentation of knuckles
3. Laboratory parameters suggestive of megaloblastic anemia with peripheral smear showing macrocytic red blood cells, hypersegmented neutrophils or thrombocytopenia or
3. Mean corpuscular volume > 90 fL or
4. Documented serum Vitamin B12 levels <100 pg/mL will be enrolled
1. Children on drugs likely to cause peripheral blood megaloblastosis like Phenytoin/Valproate and chemotherapeutic drugs like Methotrexate
2. Hemodynamically unstable children
3. Children already on any form of vitamin B12 supplementation for more than 2 weeks
4. Patients with chronic gastrointestinal disorders/ malabsorption like coeliac disease, inflammatory bowel disease, short bowel syndrome or surgical causes.
5. Patient/caregivers not giving consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success in improvemnet of serum vitamin B12 levels, haemoglobin & mean corpuscular volume over 3 months periodTimepoint: 3 months
- Secondary Outcome Measures
Name Time Method acceptance & safety of oral v/s intramuscular vitamin B12 supplementation among children with nutritional megaloblastic anemiaTimepoint: 3 months