Recruitment

Recruitment Status
Completed
Estimated Enrollment
718

Inclusion Criterias

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

Exclusion Criterias

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

Summary

Conditions
  • Acute Bronchiolitis
  • Acute Bronchitis
  • Upper Respiratory Tract Infection
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Younger than 19 years
Gender
Both males and females

Inclusion Criterias

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

Exclusion Criterias

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

Locations

Barcelona, 08035
Barcelona, 08035

Tracking Information

NCT #
NCT01875757
Collaborators
Not Provided
Investigators
Study Chair: Antonio Moreno, MD, PhD Hospital Universitari Vall d'hebron Barcelona, Spain