Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life (VitDBR2012)
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.
|Acute Bronchitis Upper Respiratory Tract Infection Acute Bronchiolitis||Drug: Vitamin D3 Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
|Official Title:||Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life|
- Percentage of children with acute bronchitis [ Time Frame: 1 year ]Check that the administration of a vitamin D dose of 1,000 U / day decreases the percentage of children with acute bronchitis during the first year of life
- Number of episodes of upper respiratory infections reported by parents in the first year of life [ Time Frame: 1 year ]Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections
- Percentage of children with recurrent bronchitis [ Time Frame: 1 year ]Check that the supplementation of vitamin D of 1,000 units / day decreases the number of recurrent bronchitis
|Study Start Date:||November 2013|
|Study Completion Date:||December 2016|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D3 1000 IU/day
Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 1.000 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
|Drug: Vitamin D3 Drug: Placebo|
Active Comparator: Vitamin D3 400 IU/day
Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 400 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
|Drug: Vitamin D3 Drug: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01875757
|Hospital Universitary Vall d'Hebron|
|Barcelona, Spain, 08035|
|Study Chair:||Antonio Moreno, MD, PhD||Hospital Universitari Vall d'Hebron, Barcelona, Spain|