Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life

Conditions
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Acute Bronchitis, Upper Respiratory Tract Infection, Acute Bronchiolitis

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 19 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 1000 IU/day<br>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<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Vitamin D3 400 IU/day<br>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<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children with acute bronchitis | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of upper respiratory infections reported by parents in the first year of life | Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Acute bronchitis, Upper respiratory tract infection, Recurrent bronchitis, Acute bronchiolitis, Infants