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A Randomized, Double‐Blind, Placebo‐Controlled Study of Oral Vitamin B 12 Supplementation in Older Patients with Subnormal or Borderline Serum Vitamin B 12 Concentrations
Author(s) -
Seal Eric C.,
Metz Jack,
Flicker Leon,
Melny Joy
Publication year - 2002
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1046/j.1532-5415.2002.50020.x
Subject(s) - medicine , cobalamin , cyanocobalamin , vitamin b12 , placebo , homocysteine , gastroenterology , malabsorption , creatinine , methylmalonic acid , b vitamins , anemia , vitamin , pernicious anemia , endocrinology , alternative medicine , pathology
OBJECTIVES: To determine the effect of small doses of oral cyanocobalamin supplements in older patients with low or borderline serum vitamin B 12 concentrations but no other evidence of pernicious anemia (PA). DESIGN: Randomized, double‐blind, placebo‐controlled study assessing the efficacy of oral cyanocobalamin 10 μg and 50 μg daily for 1 month. SETTING: Two geriatric hospitals in the North Western Health Care Network, Melbourne, Australia. PARTICIPANTS: Thirty‐one inpatients with serum vitamin B 12 levels between 100 and 150 pmol/L, without PA, other malabsorption disorders, or progressive neurological or terminal illness. The mean age was 81.4 years. INTERVENTION: After informed consent, a medical and drug history was taken and the Mini‐Mental State Examination (MMSE) completed. A dietitian made assessment of oral cobalamin intake. Blood was taken for serum vitamin B 12 , serum and red cell folate assay, full blood examination, fasting serum gastrin, parietal and intrinsic factor antibodies, fasting serum homocysteine, and creatinine. Patients were then randomized to receive 10 μg oral cyanocobalamin, 50 μg oral cyanocobalamin, or placebo treatment for 1 month, after which the investigations and clinical examinations were repeated. MEASUREMENTS: Percentage change in the level of vitamin B 12 , homocysteine, folate, and red cell parameters and absolute changes in MMSE were calculated and compared between groups. The groups were compared on the number of responders who improved their level of B 12 by 20%. Chi‐square calculations on changes in serum vitamin B 12 concentration were also performed. RESULTS: Mean serum vitamin B 12 ± standard deviation improved by 51.7 ± 47.1% in the 50‐μg group, 40.2 ± 34.4% in the 10‐μg group, and 11.7 ± 24.5% in the placebo group. The change in the 50‐μg cyanocobalamin group was significantly greater than that in the placebo group ( P = .044). The change in the 10‐μg cyanocobalamin group was not significantly different from that in the placebo group ( P = .186). Eight of 10 subjects in each treatment group were classified as responders, compared with two of 11 in the placebo group ( P = .004). Homocysteine levels fell in patients receiving cyanocobalamin, but this fall failed to reach statistical significance. There were no significant changes in the other parameters measured. CONCLUSION: Cyanocobalamin supplementation of 50 μg but not 10 μg daily produced a significant increase in serum vitamin B 12 . This result has implications for the management of patients with subnormal or borderline serum vitamin B 12 concentrations and for food fortification with vitamin B 12 .