Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder.

BACKGROUND: Autism spectrum disorder (ASD) is a frequent developmental disorder characterized by pervasive deficits in social interaction, impairment in verbal and nonverbal communication, and stereotyped patterns of interests and activities. It has been previously reported that there is vitamin D deficiency in autistic children; however, there is a lack of randomized controlled trials of vitamin D supplementation in ASD children. METHODS: This study is a double-blinded, randomized clinical trial (RCT) that was conducted on 109 children with ASD (85 boys and 24 girls; aged 3-10 years). The aim of this study was to assess the effects of vitamin D supplementation on the core symptoms of autism in children. ASD patients were randomized to receive vitamin D3 or placebo for 4 months. The serum levels of 25-hydroxycholecalciferol (25 (OH)D) were measured at the beginning and at the end of the study. The autism severity and social maturity of the children were assessed by the Childhood Autism Rating Scale (CARS), Aberrant Behavior Checklist (ABC), Social Responsiveness Scale (SRS), and the Autism Treatment Evaluation Checklist (ATEC). TRIAL REGISTRATION NUMBER: UMIN-CTR Study Design: trial number: UMIN000020281. RESULTS: Supplementation of vitamin D was well tolerated by the ASD children. The daily doses used in the therapy group was 300 IU vitamin D3/kg/day, not to exceed 5,000 IU/day. The autism symptoms of the children improved significantly, following 4-month vitamin D3 supplementation, but not in the placebo group. This study demonstrates the efficacy and tolerability of high doses of vitamin D3 in children with ASD. CONCLUSIONS: This study is the first double-blinded RCT proving the efficacy of vitamin D3 in ASD patients. Depending on the parameters measured in the study, oral vitamin D supplementation may safely improve signs and symptoms of ASD and could be recommended for children with ASD. At this stage, this study is a single RCT with a small number of patients, and a great deal of additional wide-scale studies are needed to critically validate the efficacy of vitamin D in ASD.

Effects of bovine colostrum on recurrent respiratory tract infections and diarrhea in children.

BACKGROUND: Bovine colostrum (BC) has direct antimicrobial and endotoxin-neutralizing effects throughout the alimentary tract, as well as other bioactivities that suppress gut inflammation and promote mucosal integrity and tissue repair under various conditions related to tissue injury. The precise role of BC in respiratory and gastrointestinal (GI) infections in children is not well defined. The aim of this study was to evaluate the efficacy and tolerability of BC administration in preventing recurrent upper respiratory tract infections (URTI) and diarrhea in children. METHODS: One hundred sixty children (aged 1-6 years) having recurrent episodes of URTI or diarrhea received BC for 4 weeks. The number of episodes of URTI, diarrhea, and frequency of hospitalization required for URTI and diarrhea occurring during the study period were assessed at weeks 8 and 24. RESULTS: From a total number of 160 children, 81 patients (50.63%) were males. The mean age (± SD) was 3.65 (± 2.01) years. The mean (± SD) total number of infections was significantly decreased after BC therapy from 8.6 ±â€Š5.1 at baseline to 5.5 ±â€Š1.2 after 2 months (P < 0.001) and to 5.7 ±â€Š1.6 after 6 months (P < 0.001). The mean (± SD) total number of URTI (P < 0.0001), number of episodes of diarrhea (P < 0.001), and number of hospital admissions (P < 0.001) were significantly decreased after BC therapy. CONCLUSION: BC is effective in the prophylaxis of recurrent URTI and diarrhea as it reduces the number of episodes and the hospitalization due to these infections. Results of this study suggest that BC could be provided as a therapeutic option for children with recurrent URTI and diarrhea.