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Randomized controlled trial of vitamin B12 supplementation in Mexican women with a high prevalence of B12 deficiency; predictors of biochemical and hematological response
Author(s) -
ShahabFerdows Setareh,
Anaya Miriam Aracely,
Rosado Jorge Louis,
Pogribny Igor,
Allen Lindsay H.
Publication year - 2008
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.22.1_supplement.296.5
Subject(s) - medicine , vitamin b12 , endocrinology , placebo , methylmalonic acid , gastroenterology , randomized controlled trial , alternative medicine , pathology
Low serum B12 (sB12) is prevalent in Latin America. This randomized controlled trial assessed functional significance of low sB12 from response to supplementation of women aged 18–59 in rural Querétaro. Subjects were assigned to B12 (1 dose 1 mg i.m. + 500 ug/d oral, 3 mo, n=70) or placebo (n=62). Measures at baseline and 3 mo were CBC; sB12, holotranscobalamin (TC), folate, MMA; tHcy; DNA methylation, bone alkaline phosphatase (BAP). At baseline 10% were B12 deficient (sB12 <150 pmol/L) and 21% marginal (150–220 pmol/L). TC was low (<35 pmol/L) in 22% and correlated with sB12 (r=0.7, P<0.001). MMA >270 nmol/L and tHcy>12μmol/L occurred in 17% and 35%, and correlated with sB12 (r= −0.28, P<0.0007, and r=−0.20, P<0.01) indicating functional deficiency. Supplementation sig. increased sB12 by 384 pmol/L and holoTC by 80 pmol/L, lowered MMA by 55 nmol/L and tHcy by 1.3 μmol/L, but had no sig. effect on hematology, BAP or DNA. Defining responders to B12 as above the placebo group's regression line for sB12 and TC or below for MMA and tHcy, 79% responded in sB12, 70% TC, 17% MMA, 15% tHcy, 46% in sB12 + TC, but only 1% in all 4 measures. Greater response in SB12 was predicted by higher baseline tHcy and lower gastrin; in TC by younger age and lower gastrin; BAP by higher MMA; tHcy by no baseline variable. Functional B12 deficiency was confirmed but variable response of B12 status markers complicates evaluation of intervention efficacy. UCMexus & USDA.