Nature and science of sleep · 2020
Effects of Lactoferrin on Sleep Conditions in Children Aged 12-32 Months: A Preliminary, Randomized, Double-Blind, Placebo-Controlled Trial.
Клинический случайКлиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Miyakawa Momoko, Kubo Shutaro, Oda Hirotsugu, Motoki Noriko, Mizuki Masaru, Tsukahara Teruomi, Tanaka Miyuki, Yamauchi Koji, Abe Fumiaki, Nomiyama Tetsuo
Аннотация
PURPOSE: To investigate preliminarily the effect of lactoferrin (LF)-fortified formula on sleep conditions in children.
STUDY DESIGN: A preliminary, randomized, double-blind, placebo-controlled trial.
METHODS: Healthy children between the ages of 12 and 32 months who attended nursery schools in Japan were divided into two groups and assigned a placebo or LF (48 mg/day)-fortified formula. Children's sleep conditions were investigated before and after the 13-week intervention using the Japanese Sleep Questionnaire for Preschoolers (JSQ-P).
RESULTS: Altogether, 109 participants were randomized. Eight participants were eliminated due to lost to follow-up, withdrawal of consent, and ineligibility, with 101 participants (placebo, n = 48; LF, n = 53) included in the full analysis set (FAS) and used for analysis. Wake-up time, bedtime, and nighttime sleep were comparable between the two groups before and after intervention. The change in total JSQ-P T scores tended to improve in the LF group (placebo vs LF: 0.5 ± 6.5 vs -1.9 ± 6.1, p = 0.074), in particular, morning symptoms significantly improved (grumpy in the morning, hard to wake-up, and hard to get out of bed) (placebo vs LF: 0.8 ± 6.2 vs -1.9 ± 6.2, p = 0.028). A better trend was also observed in the LF group regarding restless legs syndrome (RLS)-motor (rubs feet at night and touches feet at night) (placebo vs LF: 2.3 ± 10.7 vs -0.6 ± 13.5, p = 0.083) and insufficient sleep (stays up more than one hour later the day before a holiday and wakes up more than one hour later on a holiday) (placebo vs LF: 0.1 ± 9.8 vs -1.7 ± 8.8, p = 0.095). No adverse drug reactions were found.
CONCLUSION: LF intake may improve sleep condition, especially morning symptoms in children above one year of age.
STUDY DESIGN: A preliminary, randomized, double-blind, placebo-controlled trial.
METHODS: Healthy children between the ages of 12 and 32 months who attended nursery schools in Japan were divided into two groups and assigned a placebo or LF (48 mg/day)-fortified formula. Children's sleep conditions were investigated before and after the 13-week intervention using the Japanese Sleep Questionnaire for Preschoolers (JSQ-P).
RESULTS: Altogether, 109 participants were randomized. Eight participants were eliminated due to lost to follow-up, withdrawal of consent, and ineligibility, with 101 participants (placebo, n = 48; LF, n = 53) included in the full analysis set (FAS) and used for analysis. Wake-up time, bedtime, and nighttime sleep were comparable between the two groups before and after intervention. The change in total JSQ-P T scores tended to improve in the LF group (placebo vs LF: 0.5 ± 6.5 vs -1.9 ± 6.1, p = 0.074), in particular, morning symptoms significantly improved (grumpy in the morning, hard to wake-up, and hard to get out of bed) (placebo vs LF: 0.8 ± 6.2 vs -1.9 ± 6.2, p = 0.028). A better trend was also observed in the LF group regarding restless legs syndrome (RLS)-motor (rubs feet at night and touches feet at night) (placebo vs LF: 2.3 ± 10.7 vs -0.6 ± 13.5, p = 0.083) and insufficient sleep (stays up more than one hour later the day before a holiday and wakes up more than one hour later on a holiday) (placebo vs LF: 0.1 ± 9.8 vs -1.7 ± 8.8, p = 0.095). No adverse drug reactions were found.
CONCLUSION: LF intake may improve sleep condition, especially morning symptoms in children above one year of age.