Oral vitamin B12 for patients suspected of subtle cobalamin deficiency: a multicentre pragmatic randomised controlled trial.

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Version: Final published version
Serval ID
serval:BIB_BEB9A2624BB7
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Oral vitamin B12 for patients suspected of subtle cobalamin deficiency: a multicentre pragmatic randomised controlled trial.
Journal
Bmc Family Practice
Author(s)
Favrat B., Vaucher P., Herzig L., Burnand B., Ali G., Boulat O., Bischoff T., Verdon F.
ISSN
1471-2296 (Electronic)
ISSN-L
1471-2296
Publication state
Published
Issued date
2011
Peer-reviewed
Oui
Volume
12
Number
1
Pages
2
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: epublish
Abstract
BACKGROUND: Evidence regarding the effectiveness of oral vitamin B12 in patients with serum vitamin B12 levels between 125-200 pM/l is lacking. We compared the effectiveness of one-month oral vitamin B12 supplementation in patients with a subtle vitamin B12 deficiency to that of a placebo.
METHODS: This multicentre (13 general practices, two nursing homes, and one primary care center in western Switzerland), parallel, randomised, controlled, closed-label, observer-blind trial included 50 patients with serum vitamin B12 levels between 125-200 pM/l who were randomized to receive either oral vitamin B12 (1000 μg daily, N = 26) or placebo (N = 24) for four weeks. The institution's pharmacist used simple randomisation to generate a table and allocate treatments. The primary outcome was the change in serum methylmalonic acid (MMA) levels after one month of treatment. Secondary outcomes were changes in total homocysteine and serum vitamin B12 levels. Blood samples were centralised for analysis and adherence to treatment was verified by an electronic device (MEMS; Aardex Europe, Switzerland). Trial registration: ISRCTN 22063938.
RESULTS: Baseline characteristics and adherence to treatment were similar in both groups. After one month, one patient in the placebo group was lost to follow-up. Data were evaluated by intention-to-treat analysis. One month of vitamin B12 treatment (N = 26) lowered serum MMA levels by 0.13 μmol/l (95%CI 0.06-0.19) more than the change observed in the placebo group (N = 23). The number of patients needed to treat to detect a metabolic response in MMA after one month was 2.6 (95% CI 1.7-6.4). A significant change was observed for the B12 serum level, but not for the homocysteine level, hematocrit, or mean corpuscular volume. After three months without active treatment (at four months), significant differences in MMA levels were no longer detected.
CONCLUSIONS: Oral vitamin B12 treatment normalised the metabolic markers of vitamin B12 deficiency. However, a one-month daily treatment with 1000 μg oral vitamin B12 was not sufficient to normalise the deficiency markers for four months, and treatment had no effect on haematological signs of B12 deficiency.
Keywords
Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Biological Markers/blood, Blood Specimen Collection, Dietary Supplements, Female, Follow-Up Studies, Homocysteine/blood, Humans, Least-Squares Analysis, Male, Methylmalonic Acid/blood, Middle Aged, Patient Compliance, Switzerland, Treatment Outcome, Vitamin B 12/administration & dosage, Vitamin B 12/blood, Vitamin B 12 Deficiency/blood, Vitamin B 12 Deficiency/drug therapy, Vitamin B Complex/administration & dosage, Vitamin B Complex/blood, Young Adult
Pubmed
Web of science
Open Access
Yes
Create date
04/02/2011 8:19
Last modification date
20/08/2019 15:33
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