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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Systematic Review
Population
children with vitamin B12 deficiency anemia
Methods
systematic review of RCTs comparing parenteral vs oral B12 supplementation; included one eligible RCT where children received 1 dose of 1000 µg parenterally before being randomized to either parenteral or oral therapy
Duration
3 months

Context

Vitamin B12 deficiency in children is treated with either parenteral or oral supplementation. Although the efficacy of supplementation is reportedly comparable for the 2 routes in adults, there is limited data for children.

Objective

The objective of this review was to compare the efficacy and safety of parenteral vs oral B12 supplementation in children with vitamin B12 deficiency anemia.

Data sources

A comprehensive literature search was conducted in PubMed, EMBASE, the Cochrane Library, Scopus, Web of Science, four Clinical Trials Registries, and 2 gray literature databases, for randomized controlled trials (RCTs) comparing the parenteral vs oral routes of administering B12 in children with vitamin B12 deficiency anemia.

Data extraction

Among 6467 citations screened, there was only 1 eligible RCT, in which children with vitamin B12 deficiency anemia received 1 dose of 1000 µg parenterally before being randomized to either parenteral or oral therapy.

Data analysis

After 3 months, the parenteral route resulted in higher B12 levels compared with the oral route (median [459, 835] vs 506 [399, 726] pg/mL). The changes from baseline in vitamin B12 levels (median [389, 775] vs 399 [313, 606] pg/mL, P = .016) and hemoglobin (2.7 [0.4, 4.6] vs 0.5 [-0.1, 1.2] g/dL, P = .001) were also significantly greater with the parenteral route. There was no data on safety. In terms of quality, the RCT was judged to be at "high risk of bias."

Conclusion

Limited evidence from a single, methodologically weak RCT suggested that the parenteral route is more efficacious than the oral route. However, considering the limitations in quality and quantity of the available evidence, this should be interpreted with caution.

Systematic review registration

PROSPERO registration No. CRD42024526597.

Research Insights

  • The changes from baseline in ... hemoglobin (2.7 [0.4, 4.6] vs 0.5 [-0.1, 1.2] g/dL, P = .001) were also significantly greater with the parenteral route.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    1000 µg initially parenterally followed by parenteral or oral therapy (dose not specified for maintenance)
  • After 3 months, the parenteral route resulted in higher B12 levels compared with the oral route (median [IQR]: 653 [459, 835] vs 506 [399, 726] pg/mL). The changes from baseline in vitamin B12 levels (median [IQR]: 600 [389, 775] vs 399 [313, 606] pg/mL, P = .016) were also significantly greater with the parenteral route.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    1000 µg initially parenterally followed by parenteral or oral therapy (dose not specified for maintenance)
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