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

NCT01875757 | Completed Phase 3

• 1 other identifier: 2012-001152-19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Bronchitis; Upper Respiratory Tract Infection; Acute Bronchiolitis

Keywords

Vitamin D; Acute bronchitis; Upper respiratory tract infection; Recurrent bronchitis; Acute bronchiolitis; Infants

Outcome Measures

Primary Outcomes (1)

• Percentage of children with acute bronchitis

  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

  1 year

Secondary Outcomes (1)

• Number of episodes of upper respiratory infections reported by parents in the first year of life

  1 year

Other Outcomes (1)

• Percentage of children with recurrent bronchitis

  1 year

Study Arms (2)

Vitamin D3 1000 IU/day

EXPERIMENTAL

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

Vitamin D3 400 IU/day

ACTIVE COMPARATOR

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

Interventions

Vitamin D3 DRUG

Vitamin D3 1000 IU/day; Vitamin D3 400 IU/day

Placebo DRUG

Vitamin D3 1000 IU/day; Vitamin D3 400 IU/day

Eligibility Criteria

• Age: Up to 19 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitary Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (6)

• Camargo CA Jr, Ingham T, Wickens K, Thadhani R, Silvers KM, Epton MJ, Town GI, Pattemore PK, Espinola JA, Crane J; New Zealand Asthma and Allergy Cohort Study Group. Cord-blood 25-hydroxyvitamin D levels and risk of respiratory infection, wheezing, and asthma. Pediatrics. 2011 Jan;127(1):e180-7. doi: 10.1542/peds.2010-0442. Epub 2010 Dec 27.

  PMID: 21187313 BACKGROUND

• Belderbos ME, Houben ML, Wilbrink B, Lentjes E, Bloemen EM, Kimpen JL, Rovers M, Bont L. Cord blood vitamin D deficiency is associated with respiratory syncytial virus bronchiolitis. Pediatrics. 2011 Jun;127(6):e1513-20. doi: 10.1542/peds.2010-3054. Epub 2011 May 9.

  PMID: 21555499 BACKGROUND

• Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009 Apr;63(4):473-7. doi: 10.1038/sj.ejcn.1602960. Epub 2007 Nov 21.

  PMID: 18030309 BACKGROUND

• Urashima M, Segawa T, Okazaki M, Kurihara M, Wada Y, Ida H. Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin Nutr. 2010 May;91(5):1255-60. doi: 10.3945/ajcn.2009.29094. Epub 2010 Mar 10.

  PMID: 20219962 BACKGROUND

• Devereux G, Litonjua AA, Turner SW, Craig LC, McNeill G, Martindale S, Helms PJ, Seaton A, Weiss ST. Maternal vitamin D intake during pregnancy and early childhood wheezing. Am J Clin Nutr. 2007 Mar;85(3):853-9. doi: 10.1093/ajcn/85.3.853.

  PMID: 17344509 BACKGROUND

• Camargo CA Jr, Rifas-Shiman SL, Litonjua AA, Rich-Edwards JW, Weiss ST, Gold DR, Kleinman K, Gillman MW. Maternal intake of vitamin D during pregnancy and risk of recurrent wheeze in children at 3 y of age. Am J Clin Nutr. 2007 Mar;85(3):788-95. doi: 10.1093/ajcn/85.3.788.

  PMID: 17344501 BACKGROUND

MeSH Terms

Conditions

Bronchitis; Respiratory Tract Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Antonio Moreno, MD, PhD

  Hospital Universitari Vall d'hebron Barcelona, Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 12, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

ES (1)