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

NCT02617771 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-03-20

No results posted yet for this study

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

Interventions

DRUG

Vitamin D3

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

Sponsors & Collaborators

  • Policlinico Hospital

    lead OTHER

Principal Investigators

  • Maria Elisabetta Baldassarre, MD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-03-31
Completion
2015-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02617771 on ClinicalTrials.gov