Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric Primary Care.

NCT02617771 | Completed Phase 4

• 1 other identifier: VITDBA1
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D supplementation in children with RRI, with no conclusive information. Therefore, the investigators designed a prospective, single-blind, clinical trial to evaluate whether oral supplementation with vitamin D from October to April reduces the global health burden of recurrent respiratory tract infections in a primary care setting. The primary outcome was evaluated if Vitamin D supplementation during autumn and winter can reduce the number of respiratory tract infections in children diagnosed with recurrent respiratory tract infections the seasons before. Secondary objectives was the assessment of Vitamin D supplementation benefits on global socioeconomic burden of recurrent respiratory tract infections in a primary care setting, according to number of visits to the primary care paediatrician and use of antibiotics due to respiratory tract infections.

Conditions

Recurrent Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Number of recurrent respiratory tract infections for each months of study

  reduction of the number of respiratory tract infections in children diagnosed with recurrent respiratory tract infections the seasons before

  From October 1, 2014, and March 31, 2015, up to 6 months

Secondary Outcomes (1)

• Cost assessment in euros according to antibiotics, paediatric visits and vitamin D supplementation

  From October 1, 2014, and March 31, 2015, up to 6 months

Study Arms (2)

Vit D

ACTIVE COMPARATOR

Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) from October to March

Drug: Vitamin D3

Control

NO INTERVENTION

Interventions

Vitamin D3 DRUG

from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year

Vit D

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients diagnosed the seasons before with: ≥ 6 respiratory infections per annum
• ≥ 1 respiratory infections per month involving the upper airways from September to April
• ≥ 3 respiratory infections per annum involving the lower airways

You may not qualify if:

• patients with findings suggestive of an immunodeficiency on history and physical examination

Sponsors & Collaborators

• Policlinico Hospital: lead

Related Publications (2)

• de Sa Del Fiol F, Barberato-Filho S, Lopes LC, de Cassia Bergamaschi C. Vitamin D and respiratory infections. J Infect Dev Ctries. 2015 Apr 15;9(4):355-61. doi: 10.3855/jidc.5711.

  PMID: 25881523 BACKGROUND

• Zittermann A, Gummert JF. Nonclassical vitamin D action. Nutrients. 2010 Apr;2(4):408-25. doi: 10.3390/nu2040408. Epub 2010 Mar 25.

  PMID: 22254030 RESULT

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Maria Elisabetta Baldassarre, MD

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 20, 2019

Record last verified: 2019-03