Effect of supplementation with vitamin D on the acute bronchitis prevention during the first year of life.

Phase 1

Conditions: Acute bronchitisUpper airway infection
MedDRA version: 14.1Level: LLTClassification code 10000687Term: Acute bronchitisSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2012-001152-19-ES

Lead Sponsor: Antonio Moreno Galdó

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 718

Inclusion Criteria

Healthy on-term newborns of appropriate size for gestational age during the first 2 weeks of age (range 5 days), on exclusive breastfeeding or exclusive formula feeding.
Newborns whose parents authorize the inclusion in the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 718
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Infants with gestational age <37 weeks
Low birth weight for gestational age (birth weight <2,500 g)
Mixed feeding at baseline
Newborns with major congenital anomalies
Infants with chronic gastrointestinal, hepatic, renal, respiratory, cardiac, neurological, or metabolic disorders
Any disease that is accompanied by hypercalcemia and hypercalciuria, calcium lithiasis, hypersensitivity to vitamin D, hypervitaminosis D, renal osteodystrophy with hyperphosphatemia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections and recurrent bronchitis.<br><br>Check that the administration of 1,000 U / day of vitamin D decreases the percentage of children under one year of age hospitalized for acute bronchiolitis.<br><br>Check that the supplementation of vitamin D 1,000 units / day manages to get a higher percentage of children with proper blood levels of 25 OH vitamin D3.<br><br>Check that the administration of 1,000 U / day of vitamin D reduces the use of health care and absence from work of parents due to respiratory infections;Primary end point(s): Percentage of children with acute bronchitis .;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percentage of children with recurrent bronchitis.<br><br>Number of episodes of upper respiratory infections reported by parents in the first year of life<br><br>Number of infants hospitalized for acute bronchiolitis<br><br>Levels of 25-OH vitamin D3 (parameter of efficacy and safety)<br><br>Blood calcium levels and calcium / creatinine ratio in a single urination (security settings).<br><br>Growth: weight, length and head circumference (security settings).;Timepoint(s) of evaluation of this end point: 2, 6, 12 months