Bread cofortified with folic acid and vitamin B-12 improves the folate and vitamin B-12 status of healthy older people: a randomized controlled trial.
BACKGROUND
Mandatory fortification of flour with folic acid has reduced the number of neural tube defects in North America. Concerns that high intakes of folic acid might mask vitamin B-12 deficiency in older persons have delayed the introduction of fortification in many European countries. Cofortification of flour with folic acid and vitamin B-12 could simultaneously improve folate and vitamin B-12 status.


OBJECTIVE
The objective was to estimate the effect of the consumption of bread fortified with modest amounts of folic acid and vitamin B-12 on folate and vitamin B-12 status in healthy older persons living in the Netherlands, where folic acid fortification is not taking place.


METHODS
Men and women aged 50-75 y were randomly assigned in this 12-wk double-blind, placebo-controlled trial to consume bread fortified with 138 mug folic acid and 9.6 mug vitamin B-12 daily (n = 72) or unfortified bread (n = 70).


RESULTS
The consumption of fortified bread increased serum folate concentrations by 45% (mean: 6.3 nmol/L; 95% CI: 4.5, 8.1 nmol/L) and serum vitamin B-12 concentrations by 49% (mean: 102 pmol/L; 95% CI: 82, 122 pmol/L) relative to the placebo group. Fortified bread increased erythrocyte folate concentrations by 22% and holotranscobalamin concentrations by 35%; it decreased homocysteine concentrations by 13% and methylmalonic acid concentrations by 10%. Consumption of fortified bread decreased the proportion of individuals with marginal serum vitamin B-12 concentrations (<133 pmol/L) from 8% at enrollment to 0% after 12 wk.


CONCLUSIONS
Bread fortified with modest amounts of folic acid and vitamin B-12 will improve folate and vitamin B-12 status and a considerable proportion of vitamin B-12 deficiency in older people. This trial was registered at clinicaltrials.gov as NCT00353353.
Winkels
Renate M
RM
Top Institute of Food & Nutrition, Wageningen, Netherlands.
Brouwer
Ingeborg A
IA
Clarke
Robert
R
Katan
Martijn B
MB
Verhoef
Petra
P
D000368:Aged; D000375:Aging / Q000097:blood / Q000378:metabolism; D001939:Bread / Q000032:analysis; D004311:Double-Blind Method; D004912:Erythrocytes / Q000737:chemistry / Q000187:drug effects / Q000378:metabolism; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage* / Q000097:blood*; D005527:Food, Fortified; D006710:Homocysteine / Q000097:blood; D006801:Humans; D008297:Male; D008764:Methylmalonic Acid / Q000097:blood; D008875:Middle Aged; D009436:Neural Tube Defects / Q000517:prevention & control; D009751:Nutritional Requirements; D009752:Nutritional Status; D014805:Vitamin B 12 / Q000008:administration & dosage* / Q000097:blood*; D014806:Vitamin B 12 Deficiency / Q000175:diagnosis / Q000517:prevention & control
D006710:Homocysteine; D008764:Methylmalonic Acid; D005492:Folic Acid; D014805:Vitamin B 12