SUBLINGUAL TABLET OF VITAMIN B12 FOR TREATMENT OF DEFICIENCY
Not Applicable
- Conditions
- Health Condition 1: D519- Vitamin B12 deficiency anemia, unspecified
- Registration Number
- CTRI/2021/03/031845
- Lead Sponsor
- Intramural Research Grant University College of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Vitamin B12 deficient (serum cobalamin <200 ng/l) children.Vitamin B12 deficiency anemia will be defined as child with serum cobalamin <200 ng/l AND Hb <11.5 g/dl AND any one of:(1)MCV > 84+ (age in years x 0.6) fl OR (2) hypersegmented neutrophils or macrocytes on peripheral smear OR (3) bone marrow examination suggestive of megaloblastic anemia
Exclusion Criteria
Children with neurological manifestations of vitamin B12 deficiency,critical illness; proton pump inhibitors usage for >2 weeks; history of recent blood transfusion/ use of hematinics (within 12 weeks); deranged KFT; drugs like 6 MP, methotrexate, carbamazepine, valproate, phenobarbitone, phenytoin; aplastic anemia, malignancy, thalassemia, inborn error of metabolism.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum cobalamin levelsTimepoint: Day 40 of treatment
- Secondary Outcome Measures
Name Time Method (1) Change in Hb, reticulocyte hemoglobin equivalent & reticulocyte count on Day 10 and Day 40 (2) Change in Homocysteine levels on Day 40 of treatment (3) Proportion of children needing rescue therapy with IM vitamin B12 on day 10 and day 40.Timepoint: Day 10, Day 40