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Parenteral vs Oral Vitamin B12 in Children With Nutritional Macrocytic Anemia: A Randomized Controlled Trial

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Abstract

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 supplementation, 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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Funding

Funding: None

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Authors and Affiliations

  1. Department of Pediatrics, Pramukhswami Medical College, Bhaikaka University, Karamsad, 388 325, District Anand, Gujarat, India

    Rahul Tandon, Jigar Thacker &  Krutika Tandon

  2. Department of Pediatrics, Guru Gobind Singh Hospital, Jamnagar, Gujarat, India

    Utkarsh Pandya

  3. Department of Biostatistics, Central Research Service, Bhaikaka University, Karamsad, Gujarat, India

    Mamta Patel

Authors
  1. Rahul Tandon
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  2. Jigar Thacker
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  3. Utkarsh Pandya
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  4. Mamta Patel
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  5. Krutika Tandon
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Contributions

Contributors: RT, JT,: literature search, Interpretation of data, drafting the article, revising it critically for important intellectual content; UP, KT: concept and design of study, acquisition of data, analysis and interpretation of data, drafting and revising it critically for important intellectual content and final approval of the version; MP: re-analyzing data and interpretation of data, revising it critically for important intellectual content. All authors approved the final version of manuscript, and are accountable for all aspects related to the study.

Corresponding author

Correspondence to Krutika Tandon.

Ethics declarations

Ethics clearance: IEC, Pramukhswami Medical College; No. HREC/HMPCMCE/2015/129, dated March 14, 2015.

Competing interests: None stated.

Additional information

Note: Additional material related to this study is available with the online version at https://www.indianpediatrics.net

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Tandon, R., Thacker, J., Pandya, U. et al. Parenteral vs Oral Vitamin B12 in Children With Nutritional Macrocytic Anemia: A Randomized Controlled Trial. Indian Pediatr 59, 683–687 (2022). https://doi.org/10.1007/s13312-022-2594-2

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  • DOI: https://doi.org/10.1007/s13312-022-2594-2

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