Randomized controlled trial of the effects of vitamin D-fortified milk and bread on serum 25-hydroxyvitamin D concentrations in families in Denmark during winter: the VitmaD study

Background: Vitamin D intakes are lower than dietary recommendations in most populations, and thus, a low vitamin D status is widespread, especially during winter. Objective: We investigated the effects of increasing vitamin D intake to the recommended amount by fortification of milk and bread on serum 25-hydroxyvitamin D [25(OH)D] concentrations in families during winter in Denmark. Design: The study was a randomized controlled trial in 782 children and adults (4-60 y old) recruited as 201 families. Families were randomly assigned to vitamin D-fortified or nonfortified milk and bread for 6 mo starting in September. The milk and bread replaced the participants' usual consumptions of products. Results: Median (IQR) vitamin D intakes (habitual diet plus fortified products) were 9.4 mu g/d (6.5, 12.3 mu g/d) and 2.2 mu g/d (1.5, 3.0 mu g/d) in fortification and control groups, respectively. Geometric mean (IQR) serum 25(OH)D concentrations decreased from 73.1 nmol/L (61.9, 88.5 nmol/L) to 67.6 nmol/L (56.2, 79.4 nmol/L) in the fortification group and from 71.1 nmol/L (61.2, 85.9 nmol/L) to 41.7 nmol/L (29.5, 58.9 nmol/L) in the control group (both P < 0.001). The final 25(OH)D concentration was significantly higher in the fortification group than in the control group (P < 0.001). By the end of the study, <1% of subjects in the fortification group and 25% of subjects in the control group had 25(OH)D concentrations <30 nmol/L and 16% and 65% of subjects, respectively, had 25(OH)D concentrations <50 nmol/L. Conclusion: Vitamin D fortification of milk and bread reduces the decrease in serum 25(OH)D concentrations during winter and ensures 25(OH)D concentrations >50 nmol/L in children and adults in Denmark. This trial was registered at clinicaltrials.gov as NCT01184716.