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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001152-19-ES

Enrollment

718

Registered

2013-01-22

Start date

2013-02-28

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute bronchitis Upper airway infection MedDRA version: 14.1 Level: LLT Classification code 10000687 Term: Acute bronchitis System Organ Class: 100000004862

Interventions

Trade Name: VITAMINA D3 Kern Pharma Solución Oleosa Pharmaceutical Form: Oral solution INN or Proposed INN: COLECALCIFEROL CAS Number: 8000055-64-3 Other descriptive name: VITAMIN D NOS Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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. 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. 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	—

Measure

Time frame

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. 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. 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. 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

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Secondary

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

Measure

Time frame

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

—

Countries

Spain

Contacts

Public ContactAntonio Moreno Galdó

Antonio Moreno Galdó

amoreno@vhebron.net34934893171

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026