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Vitamin B₁₂ Treatment Normalizes Metabolic Markers But Has Limited Clinical Effect: A Randomized Placebo-controlled Study

¹ Department of Hematology, AAS, Aarhus University Hospital, Tage Hansens Gade 2, 8000 Aarhus C, Denmark.
² Department of Clinical Biochemistry, AKH, Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark.

^aAuthor for correspondence. Fax 45-8949-7598; e-mail am.hvas{at}dadlnet.dk.

Background: The clinical significance of increased plasma methylmalonic acid (P-MMA) is unclear. We assessed the efficacy of vitamin B₁₂ treatment in reducing P-MMA and plasma total homocysteine compared with the clinical benefits of treatment.

Methods: We studied 140 individuals with mildly to modestly increased P-MMA (0.40–2.00 µmol/L), not previously treated with vitamin B₁₂, in a randomized, placebo-controlled study. A detailed medical history was obtained, and laboratory tests as well as an objective neurologic disability score were performed at baseline and 3 months after the start of intervention.

Results: P-MMA (P <0.001) or plasma total homocysteine (P <0.001) decreased in the treatment group vs the placebo group, but no significant difference was found in the change of blood hemoglobin (P = 0.18) and mean cell volume (P = 0.71). Changes in symptom scores did not differ between the groups for symptoms of anemia (P = 0.63), neurologic symptoms (P = 0.21), gastroenterologic symptoms (P = 0.32), or the Neurological Disability Score (P = 0.85).

Conclusions: Treatment with vitamin B₁₂ reduces P-MMA and plasma total homocysteine, but individuals with a mild to modest increase in P-MMA may have only limited clinical benefit from vitamin B₁₂ treatment, at least in the short term.

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