Clinical trial NCT01723852: Vitamin D Intervention in Infants
Official title: Vitamin D Intervention in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Status
Keywords: Vitamin D
Infectious diseases
cognitive development
Bone mineral density
Immunoregulation
Allergy
Growth
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: The Finnish Governmental Special Subsidy for Health Sciences Research
name: Päivikki and Sakari Sohlberg Foundation, Finland
name: The Finnish Medical Association
First posted: 2012-11-08
Enrollment: 1000
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.


Eligibility criteria: Inclusion Criteria:

* Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study

Exclusion Criteria:

* Non Caucasian mother
* Any continuous regular medication of mother
* Treatment at neonatal intensive care unit
* Antibiotic treatment of the infant
* Congenital malformations of the newborn
* Treatment with ventilation support (continuous nasal positive airway pressure) for over 24 hours
* Glucose infusion of the newborn
* Neurological symptoms of the newborn
* Phototherapy for jaundice of the newborn
* Need for nasogastric feeding of the newborn

Primary outcomes:
measure: Growth
timeFrame: 2 years of age
measure: Neurologic and cognitive development
timeFrame: At 2 years of age
measure: Frequency of allergic symptoms and infection
timeFrame: At 2 years of age
measure: Development of immunoregulation
timeFrame: At 2 years of age
measure: Bone mineral density
timeFrame: 2 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Kätilöopisto Maternity Hospital
Study officials:
affiliation: Helsinki University Central Hospital, Children's Hospital
name: Sture Andersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmlund-Suila E, Viljakainen H, Hytinantti T, Lamberg-Allardt C, Andersson S, Makitie O. High-dose vitamin d intervention in infants--effects on vitamin d status, calcium homeostasis, and bone strength. J Clin Endocrinol Metab. 2012 Nov;97(11):4139-47. doi: 10.1210/jc.2012-1575. Epub 2012 Aug 29.
citation: Helve O, Viljakainen H, Holmlund-Suila E, Rosendahl J, Hauta-Alus H, Enlund-Cerullo M, Valkama S, Heinonen K, Raikkonen K, Hytinantti T, Makitie O, Andersson S. 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 Pediatr. 2017 Mar 29;17(1):91. doi: 10.1186/s12887-017-0845-5.
citation: Rosendahl J, Holmlund-Suila E, Helve O, Viljakainen H, Hauta-Alus H, Valkama S, Enlund-Cerullo M, Hytinantti T, Tervahartiala T, Sorsa T, Makitie O, Andersson S. 25-hydroxyvitamin D correlates with inflammatory markers in cord blood of healthy newborns. Pediatr Res. 2017 May;81(5):731-735. doi: 10.1038/pr.2017.9. Epub 2017 Jan 13.
citation: Hauta-Alus HH, Holmlund-Suila EM, Rita HJ, Enlund-Cerullo M, Rosendahl J, Valkama SM, Helve OM, Hytinantti TK, Surcel HM, Makitie OM, Andersson S, Viljakainen HT. Season, dietary factors, and physical activity modify 25-hydroxyvitamin D concentration during pregnancy. Eur J Nutr. 2018 Jun;57(4):1369-1379. doi: 10.1007/s00394-017-1417-z. Epub 2017 Mar 2.
citation: Valkama S, Holmlund-Suila E, Enlund-Cerullo M, Rosendahl J, Hauta-Alus H, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. No Severe Hypercalcemia with Daily Vitamin D3 Supplementation of up to 30 microg during the First Year of Life. Horm Res Paediatr. 2017;88(2):147-154. doi: 10.1159/000477298. Epub 2017 Jun 23.
citation: Holmlund-Suila E, Enlund-Cerullo M, Valkama S, Hauta-Alus H, Rosendahl J, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. Sex and Iron Modify Fibroblast Growth Factor 23 Concentration in 1-Year-Old Children. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4526-4533. doi: 10.1210/jc.2017-01211.
citation: Holmlund-Suila EM, Hauta-Alus HH, Enlund-Cerullo M, Rosendahl J, Valkama SM, Andersson S, Makitie O. Iron status in early childhood is modified by diet, sex and growth: Secondary analysis of a randomized controlled vitamin D trial. Clin Nutr. 2022 Feb;41(2):279-287. doi: 10.1016/j.clnu.2021.12.013. Epub 2021 Dec 13.
citation: Tuovinen S, Raikkonen K, Holmlund-Suila E, Hauta-Alus H, Helve O, Rosendahl J, Enlund-Cerullo M, Kajantie E, Valkama S, Viljakainen H, Makitie O, Andersson S, Heinonen K. Effect of High-Dose vs Standard-Dose Vitamin D Supplementation on Neurodevelopment of Healthy Term Infants: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2124493. doi: 10.1001/jamanetworkopen.2021.24493.
citation: Koljonen L, Enlund-Cerullo M, Hauta-Alus H, Holmlund-Suila E, Valkama S, Rosendahl J, Andersson S, Pekkinen M, Makitie O. Phosphate Concentrations and Modifying Factors in Healthy Children From 12 to 24 Months of Age. J Clin Endocrinol Metab. 2021 Sep 27;106(10):2865-2875. doi: 10.1210/clinem/dgab495.
citation: Hauta-Alus HH, Holmlund-Suila EM, Kajantie E, Rosendahl J, Valkama SM, Enlund-Cerullo M, Andersson S, Makitie O. The Effects of Vitamin D Supplementation During Infancy on Growth During the First 2 Years of Life. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1140-e1155. doi: 10.1210/clinem/dgaa943.
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
citation: Valkama S, Holmlund-Suila E, Ireland A, Hauta-Alus H, Enlund-Cerullo M, Rosendahl J, Andersson S, Makitie O. Peripheral quantitative computed tomography (pQCT) in 12- and 24-month-old children - Practical aspects and descriptive data. Bone. 2020 Dec;141:115670. doi: 10.1016/j.bone.2020.115670. Epub 2020 Sep 30.
citation: Enlund-Cerullo M, Hauta-Alus H, Valkama S, Rosendahl J, Andersson S, Makitie O, Holmlund-Suila E. Fibroblast growth factor 23 concentrations and modifying factors in children from age 12 to 24 months. Bone. 2020 Dec;141:115629. doi: 10.1016/j.bone.2020.115629. Epub 2020 Sep 10.
citation: Enlund-Cerullo M, Koljonen L, Holmlund-Suila E, Hauta-Alus H, Rosendahl J, Valkama S, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O, Pekkinen M. Genetic Variation of the Vitamin D Binding Protein Affects Vitamin D Status and Response to Supplementation in Infants. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5483-5498. doi: 10.1210/jc.2019-00630.
citation: Hauta-Alus HH, Kajantie E, Holmlund-Suila EM, Rosendahl J, Valkama SM, Enlund-Cerullo M, Helve OM, Hytinantti TK, Viljakainen H, Andersson S, Makitie O. High Pregnancy, Cord Blood, and Infant Vitamin D Concentrations May Predict Slower Infant Growth. J Clin Endocrinol Metab. 2019 Feb 1;104(2):397-407. doi: 10.1210/jc.2018-00602.
citation: Rosendahl J, Valkama S, Holmlund-Suila E, Enlund-Cerullo M, Hauta-Alus H, Helve O, Hytinantti T, Levalahti E, Kajantie E, Viljakainen H, Makitie O, Andersson S. Effect of Higher vs Standard Dosage of Vitamin D3 Supplementation on Bone Strength and Infection in Healthy Infants: A Randomized Clinical Trial. JAMA Pediatr. 2018 Jul 1;172(7):646-654. doi: 10.1001/jamapediatrics.2018.0602.
citation: Hauta-Alus HH, Viljakainen HT, Holmlund-Suila EM, Enlund-Cerullo M, Rosendahl J, Valkama SM, Helve OM, Hytinantti TK, Makitie OM, Andersson S. Maternal vitamin D status, gestational diabetes and infant birth size. BMC Pregnancy Childbirth. 2017 Dec 15;17(1):420. doi: 10.1186/s12884-017-1600-5.