Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01875757
Study type Interventional
Source Hospital Universitari Vall d'Hebron Research Institute
Contact
Status Completed
Phase Phase 3
Start date November 2013
Completion date December 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06052540 - Probiotic Supplementation in Children Affected by Upper Respiratory Infections N/A
Completed NCT04960878 - The Effect of Synbiotics on the Upper Respiratory Tract Infection N/A
Terminated NCT00979667 - A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection Phase 3
Recruiting NCT04479657 - Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection Early Phase 1
Completed NCT04239521 - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Recruiting NCT06065176 - The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection Phase 4
Recruiting NCT01985620 - The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate. N/A
Recruiting NCT00551382 - Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-blind, Placebo-controlled Study Phase 3
Completed NCT00393835 - A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis Phase 3
Not yet recruiting NCT05612893 - Discover the Immune Signature of Sepsis Caused by Acute Pulmonary Infection: A Cohort Study
Completed NCT06149117 - Bioequivalence Study of Azithromycin Capsule and Reference Formulation Sumamed * in Healthy Adult Subjects in China Phase 4
Active, not recruiting NCT05569330 - Effect of Aerosol Filtering on Infectious Diseases in Day Care N/A
Recruiting NCT05374070 - Antiviral Activity of Oral Probiotics N/A
Completed NCT00707941 - Oseltamivir Randomised Controlled Efficacy Trial Phase 3
Completed NCT00858494 - Homeopathic Cold Medicine for Children N/A
Completed NCT04955327 - To Compare the Efficacy and Tolerability of A. Paniculata/A. Chilensis in Individuals With URTI Phase 3
Completed NCT01735084 - Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life Phase 4
Not yet recruiting NCT03461692 - A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection(a Chinese Medicine Injection)Used in Hospitals in China N/A
Completed NCT03011515 - Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)
Recruiting NCT05915390 - Walnut and Immunity Study N/A