Clinical trial NCT01875757: Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life
Official title: Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bronchitis
Upper Respiratory Tract Infection
Acute Bronchiolitis
Keywords: Vitamin D
Acute bronchitis
Upper respiratory tract infection
Recurrent bronchitis
Acute bronchiolitis
Infants
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 200
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.

Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. A blood sample will be obtained at baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin D, and calcium.

Healthy term born infants of appropriate size for gestational age will be included. We will need to include 359 children in each group.

The primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D. Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.


Eligibility criteria: Inclusion Criteria:

* Healthy term born infants of appropriate size for gestational age
* Parents provide informed consent to participate

Exclusion Criteria:

* Infants with small size for gestational age
* Infants with gestational age \< 37 weeks
* Infants with congenital anomalies
* Infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases
* Infants with disorders of vitamin D or calcium metabolism or others inborn errors of metabolism

Primary outcomes:
measure: Percentage of children with acute bronchitis
timeFrame: 1 year
Secondary outcomes:
measure: Number of episodes of upper respiratory infections reported by parents in the first year of life
timeFrame: 1 year
Other outcomes:
measure: Percentage of children with recurrent bronchitis
timeFrame: 1 year
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitary Vall d'Hebron
Study officials:
affiliation: Hospital Universitari Vall d'hebron Barcelona, Spain
name: Antonio Moreno, MD, PhD
role: STUDY_CHAIR
References:
citation: Camargo CA Jr, Ingham T, Wickens K, Thadhani R, Silvers KM, Epton MJ, Town GI, Pattemore PK, Espinola JA, Crane J; New Zealand Asthma and Allergy Cohort Study Group. Cord-blood 25-hydroxyvitamin D levels and risk of respiratory infection, wheezing, and asthma. Pediatrics. 2011 Jan;127(1):e180-7. doi: 10.1542/peds.2010-0442. Epub 2010 Dec 27.
citation: Belderbos ME, Houben ML, Wilbrink B, Lentjes E, Bloemen EM, Kimpen JL, Rovers M, Bont L. Cord blood vitamin D deficiency is associated with respiratory syncytial virus bronchiolitis. Pediatrics. 2011 Jun;127(6):e1513-20. doi: 10.1542/peds.2010-3054. Epub 2011 May 9.
citation: Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009 Apr;63(4):473-7. doi: 10.1038/sj.ejcn.1602960. Epub 2007 Nov 21.
citation: Urashima M, Segawa T, Okazaki M, Kurihara M, Wada Y, Ida H. Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin Nutr. 2010 May;91(5):1255-60. doi: 10.3945/ajcn.2009.29094. Epub 2010 Mar 10.
citation: Devereux G, Litonjua AA, Turner SW, Craig LC, McNeill G, Martindale S, Helms PJ, Seaton A, Weiss ST. Maternal vitamin D intake during pregnancy and early childhood wheezing. Am J Clin Nutr. 2007 Mar;85(3):853-9. doi: 10.1093/ajcn/85.3.853.
citation: Camargo CA Jr, Rifas-Shiman SL, Litonjua AA, Rich-Edwards JW, Weiss ST, Gold DR, Kleinman K, Gillman MW. Maternal intake of vitamin D during pregnancy and risk of recurrent wheeze in children at 3 y of age. Am J Clin Nutr. 2007 Mar;85(3):788-95. doi: 10.1093/ajcn/85.3.788.