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Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life (VitDBR2012)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01875757
First received: June 10, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Acute Bronchitis
Upper Respiratory Tract Infection
Acute Bronchiolitis
Drug: Vitamin D3
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Percentage of children with acute bronchitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Number of episodes of upper respiratory infections reported by parents in the first year of life [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections


Other Outcome Measures:
  • Percentage of children with recurrent bronchitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Check that the supplementation of vitamin D of 1,000 units / day decreases the number of recurrent bronchitis


Estimated Enrollment: 718
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3 1000 IU/day
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 Drug: Placebo
Active Comparator: Vitamin D3 400 IU/day
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 Drug: Placebo

  Eligibility

Ages Eligible for Study:   up to 19 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875757

Locations
Spain
Hospital Universitary Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Antonio Moreno, PhD    934893171    amoreno@vheborn.net   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Study Chair: Antonio Moreno, MD, PhD Hospital Universitari Vall d'Hebron, Barcelona, Spain
  More Information

Publications:

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01875757     History of Changes
Other Study ID Numbers: 2012-001152-19, 2012-001152-19
Study First Received: June 10, 2013
Last Updated: April 10, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Vitamin D
Acute bronchitis
Upper respiratory tract infection
Recurrent bronchitis
Acute bronchiolitis
Infants

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchiolitis
Infection
Respiratory Tract Infections
Bronchial Diseases
Disease Attributes
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014