Towards evidence-based vitamin D supplementation in infants: vitamin D intervention in infants (VIDI) — study design and methods of a randomised controlled double-blinded intervention study

BMC Pediatrics

Study Protocol

Timo Hytinantti¹  Sture Andersson¹  Jenni Rosendahl¹  Maria Enlund-Cerullo¹  Otto Helve¹  Elisa Holmlund-Suila¹  Saara Valkama¹  Helena Hauta-alus¹  Heli Viljakainen²  Outi Mäkitie³  Kati Heinonen⁴  Katri Räikkönen⁴ 

[1] Children’s Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, P.O. Box 281, 00029 HUS, Helsinki, Finland;Children’s Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, P.O. Box 281, 00029 HUS, Helsinki, Finland;Folkhälsan Research Center, Helsinki, Finland;Children’s Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, P.O. Box 281, 00029 HUS, Helsinki, Finland;Folkhälsan Research Center, Helsinki, Finland;Center for Molecular Medicine, Karolinska Institutet and Clinical Genetics, Karolinska University Hospital, Stockholm, Sweden;Institute of Behavioral Sciences, University of Helsinki, Helsinki, Finland;

关键词: Allergy;    Asthma;    Bone development;    Cognitive development;    Immunity;    Infants;    Infections;    Vitamin D;   

DOI  :  10.1186/s12887-017-0845-5

 received in 2016-03-11, accepted in 2017-03-21,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundVitamin D is important for bone mass accrual during growth. Additionally, it is considered a requirement for a multitude of processes associated with, for example, the development of immunity. Many countries apply vitamin D supplementation strategies in infants, but the guidelines are not based on scientific evidence and aim at prevention of rickets. It remains unclear whether the recommended doses are sufficient for the wide array of other effects of vitamin D. The VIDI trial performed in Finland is the first large randomised controlled study for evaluation of the effects of different vitamin D supplemental doses in infancy on:bone strengthinfections and immunityallergy, atopy and asthmacognitive developmentgenetic regulation of mineral homeostasisMethods/DesignVIDI, a randomised controlled double-blinded single-centre intervention study is conducted in infants from the age of 2 weeks to 24 months. Participants, recruited at Helsinki Maternity Hospital, are randomised to receive daily either 10 μg (400 IU) or 30 μg (1 200 IU) of vitamin D3 supplementation. Both groups are assessed at 6 months of age for calcium homeostasis, and at 12 and 24 months of age for parameters associated with bone strength, growth, developmental milestones, infections, immunity, atopy-related diseases, and genetic factors involved in these functions.DiscussionThe study enables evaluation of short and long term effects of supplemental vitamin D on growth, immune functions and skeletal and developmental parameters in infants, and the effects of genetic factors therein. The results enable institution of evidence-based guidelines for vitamin D supplementation in infancy.Trial registrationClinicalTrials.gov, NCT01723852, registration date 6.11.2012.

【 授权许可】

CC BY   
© The Author(s). 2017