Vitamin D fortification of growing up milk prevents decrease of serum 25-hydroxyvitamin D concentrations during winter: a clinical intervention study in Germany.

Vitamin D plays an important role in human health. Current recommendations for vitamin D intake and endogenous supply through sun exposure are not met in German pre-school children, and suboptimal serum 25-hydroxyvitamin D concentrations, especially during the winter months, are common. Consequently, vitamin D supplementation or fortification have gained increased acceptance. The KiMi trial (Kindermilch=growing up milk) was a prospective, randomized, and double-blind study in which young children (2-6 years of age, n=92) were assigned to receive either vitamin D-fortified growing up milk (2.85 µg/100 ml) or semi skimmed cow's milk without added vitamin D. Daily consumption of fortified growing up milk contributed to the prevention of an otherwise frequently observed decrease in serum 25-hydroxyvitamin D concentration during winter (before winter: median 21.5 ng/mL (10.1-43.0 ng/mL) intervention vs. median 18.4 ng/mL (11.0-44.9 ng/mL) control; after winter: median 24.8 ng/mL (7.0-48.2 ng/mL) intervention vs. median 13.6 ng/mL (7.0-36.8 ng/mL) control) and proved to be safe during summer (median 27.6 ng/mL (18.8-40.5 ng/mL) intervention vs. median 27.4 ng/mL (17.8-38.7 ng/mL) control). Due to the high prevalence of vitamin D deficiency, fortification of growing up milk with vitamin D at a level used in this study could be an effective measure to improve vitamin D status.

Lactobacillus fermentum CECT 5716 is safe and well tolerated in infants of 1-6 months of age: a randomized controlled trial.

The objective of the study was to evaluate the safety and tolerance of an infant formula supplemented with Lactobacillus fermentum CECT5716, a probiotic strain isolated from breast milk, in infants of 1-6 months of age. A randomized double blinded controlled study including healthy infants was conducted. One month aged infants received a prebiotic infant formula supplemented with L. fermentum (experimental group) or the same formula without the probiotic strain (control group) for 5 months. The primary outcome of the study was average daily weight gain between baseline and 4 months of age. Secondary outcomes were other anthropometric data (length and head circumference), formula consumption, and tolerance. Incidence of infections was also recorded by pediatricians. No significant differences in weight gain were observed between both groups, neither at 4 months of age (29.0±7.8 vs 28.9±5.7g/day) nor at 6 months (25.1±6.1 vs 24.7±5.2g/day). There were no statistically significant differences in the consumption of the formulae or symptoms related to the tolerance of the formula. The incidence rate of gastrointestinal infections in infants of the control group was 3 times higher than in the probiotic group (p=0.018). Therefore, consumption of a prebiotic infant formula enriched with the human milk probiotic strain L. fermentum CECT5716 from 1 to 6 months of life is well tolerated and safe. Furthermore, the consumption of this formula may improve the health of the infants by reducing the incidence of gastrointestinal infections.