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Parenteral vs Oral Vitamin B12 in Children With Nutritional Macrocytic Anemia: A Randomized Controlled Trial
Rahul Tandon1, Jigar Thacker1, Utkarsh Pandya2
1Department of Pediatrics, Pramukhswami Medical College, Bhaikaka University, Karamsad, Gujarat.
Insights
Parenteral vitamin B12 therapy led to significantly higher serum vitamin B12 levels and hemoglobin increase compared to oral therapy in children with vitamin B12 deficiency anemia. This study highlights parenteral administration as a more effective route for treating this condition in pediatric patients.
Area of Science:
- Pediatric Hematology
- Nutritional Science
- Clinical Trials
Background:
- Limited research exists on the efficacy of different vitamin B12 administration routes for treating vitamin B12 deficiency macrocytic-megaloblastic anemia in children.
- Nutritional macrocytic anemia is a significant concern in pediatric populations, requiring effective treatment strategies.
Purpose of the Study:
- To compare the effectiveness of parenteral versus oral vitamin B12 therapy in children diagnosed with macrocytic-megaloblastic anemia.
- To evaluate the impact of different vitamin B12 administration routes on hematological parameters and vitamin B12 levels in pediatric patients.
Main Methods:
- A single-center, open-label randomized controlled trial was conducted involving 80 children aged 2 months to 18 years with nutritional macrocytic anemia.
- Participants received an initial parenteral dose of vitamin B12, followed by randomization to either intramuscular (IM) parenteral or daily oral vitamin B12 for three months.
- Serum vitamin B12 levels and hemoglobin were measured and compared three months post-treatment.
Main Results:
- Children receiving parenteral vitamin B12 (Group A) showed a significantly greater increase in serum vitamin B12 levels compared to those receiving oral vitamin B12 (Group B).
- The rise in hemoglobin levels was also significantly more pronounced in the parenteral vitamin B12 group compared to the oral group.
- P-values for the differences in serum vitamin B12 and hemoglobin increases were P=0.016 and P=0.001, respectively.
Conclusions:
- Parenteral administration of vitamin B12 resulted in superior increases in both serum vitamin B12 levels and hemoglobin compared to oral administration in children with nutritional macrocytic anemia.
- The findings suggest that parenteral vitamin B12 is a more effective route for treating vitamin B12 deficiency macrocytic-megaloblastic anemia in the pediatric population.
Background:
There is limited literature in children on efficacy of different routes of vitamin B12 administration for vitamin B12 deficiency macrocytic-megaloblastic anemia.
Objective:
To compare parenteral with oral vitamin B12 therapy in children with macrocytic-megaloblastic anemia.
Study Design:
Single-center, open-label randomized controlled trial.
Participant:
80 children aged 2 month-18 year with clinical and laboratory features of nutritional macrocytic anemia.
Intervention:
All children received an initial single parenteral dose of 1000 µg vitamin B12 followed by randomization to either parenteral or oral vitamin B12 for subsequent doses. Group A was given 1000 µg intramuscular (IM) vitamin B12 (3 doses on alternate days for those aged <10 year, five doses for age >10 year), followed by monthly 1000 µg IM for the subsequent two doses. Group B was given daily oral vitamin B12 1500 µg (500 µg in <2 years age) for three months. Folic acid and iron supple-mentation, and relevant dietary advice were given to both groups in a similar fashion.
Outcome:
Improvement in serum vitamin B12 levels and total hemoglobin was compared three months post-treatment.
Result:
The median(IQR) increase in serum vitamin B12 level was significantly higher in group A [600 (389,775) vs 399 (313, 606) pg/mL; P= 0.016]. The median (IQR) rise of hemoglobin was also more in group A [2.7 (0.4,4.6) vs 0.5 (-0.1,1.2) g/dL; P=0.001].
Conclusion:
Increase in serum vitamin B12 levels and hemoglobin was better in children with nutritional macrocytic anemia receiving parenteral as compared to oral vitamin B12.
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