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

• Published in: Pediatrics international Vol. 65; no. 1; pp. e15359 - n/a
• Main Authors: Takahashi, Naoto, Shoji, Hiromichi, Arai, Hiroko, Tanaka, Kyoko, Kakiuchi, Satsuki, Yoda, Hitoshi, Shimizu, Toshiaki
• Format: Journal Article
• Language: English
• Published: Australia Blackwell Publishing Ltd 01.01.2023
• Subjects: Age; Babies; Baby foods; Biotin; Breast; Breast Feeding; Child, Preschool; development; Dietary Supplements; Female; Humans; Infant; Infant Formula; Infant formulas; Infants; Japan; Pediatrics; skin; Statistical analysis; urine; Japan; skin; development; infant; urine; biotin
• ISSN: 1328-8067; 1442-200X
• DOI: 10.1111/ped.15359

Background This non‐randomized intervention study aimed to evaluate the effect of supplementing infant formula with biotin on biotin metabolism and on development. Methods 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. Results 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. Conclusions 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.