Effect of biotin supplementation in infant formula: A multi-center study in Japan

This non-randomized intervention study aimed to evaluate the effect of supplementing infant formula with biotin on biotin metabolism and on development.

We enrolled healthy Japanese infants (n = 84) and assigned them to groups offered Formula A (total biotin, 0.5 μg/100 kcal) or Formula B (total biotin, 2.4 μg/100 kcal) until they were 6 months of age, and completed an additional follow up to age 36 months. Urinary biotin concentrations were measured at 1 and 6 months, and were compared among breast-fed, Formula A-fed, and Formula B-fed infants at each age. In a follow-up subgroup analysis, we compared scores on the Ages and Stages Questionnaire, version 3 (ASQ-3), from 9 to 36 months among infants continuously fed Formula A, Formula B, or breastmilk.

No adverse events occurred during the intervention period. At 1 month, urinary biotin concentrations were highest in Formula B-fed infants and lowest in Formula A-fed infants. At 6 months, Formula B-fed infants retained higher biotin levels than Formula A-fed and breast-fed infants. Both differences were statistically significant (P < 0.05). The breast-fed, Formula A-fed, and Formula B-fed groups had similar ASQ scores at 9-36 months.

Biotin supplementation of infant formula contributed to improving biotin status in formula-fed infants. The results support the official approval of the use of biotin in infant formula by the government of Japan in 2014.