Overview

This trial is active, not recruiting.

Conditions upper respiratory tract infections, lower respiratory tract infections
Treatments vitamin d3, placebo
Phase phase 3
Sponsor The Hospital for Sick Children
Collaborator International Centre for Diarrhoeal Disease Research, Bangladesh
Start date December 2014
End date September 2016
Trial size 1213 participants
Trial identifier NCT02388516, 1000039072-ARI

Summary

There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh. Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B) incidence of clinical ARI (without the need for positive microbiology), and C) quantitative density of pneumococcal carriage. Infants will be followed from birth until 6 months of life. Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
Prenatal Period 0 IU; Postpartum Period 0 IU (placebo) Overall: The Prenatal Period will start at enrolment (17-24 weeks gestation) and last until delivery. The Postpartum Period will last from delivery until 6 months postpartum.
placebo
(Experimental)
Prenatal Period 4,200 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)
vitamin d3 Cholecalciferol
(Experimental)
Prenatal Period 16,800 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)
vitamin d3 Cholecalciferol
(Experimental)
Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)
vitamin d3 Cholecalciferol
(Experimental)
Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 28,000 IU/week
vitamin d3 Cholecalciferol

Primary Outcomes

Measure
Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI)
time frame: 0 to 6 months

Secondary Outcomes

Measure
ARI with microbiologically confirmed influenza A or B
time frame: 0 to 6 months
ARI with microbiologically confirmed RSV
time frame: 0 to 6 months
Clinical URTI and/or LRTI (i.e., no microbiological confirmation)
time frame: 0 to 6 months
Clinical URTI (i.e., no microbiological confirmation)
time frame: 0 to 6 months
Clinical LRTI (i.e., no microbiological confirmation)
time frame: 0 to 6 months
Quantitative S. pneumoniae nasal carriage density
time frame: 0 to 6 months
Pneumonia (non-severe) and severe pneumonia or very severe disease
time frame: 2 to 6 months

Eligibility Criteria

Male or female participants up to 26 weeks old.

Inclusion Criteria: - Infants born to women enrolled in the MDIG trial (NCT01924013). - Maternal inclusion criteria (at time of enrolment) will be: - At least 18 years of age - 17 to 24 completed weeks of gestation - Intends to permanently reside in the trial catchment area for at least 18 months - Family plans to reside in catchment area for the first 6 months postnatal - Provides written informed consent for participation Exclusion Criteria: - Mother withdrawn from MDIG trial prior to delivery - Failure to provide consent for participation in sub-study

Additional Information

Official title Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI): a Nested Sub-study in a Randomized Controlled Trial of Vitamin D Supplementation During Pregnancy and Lactation in Dhaka, Bangladesh
Principal investigator Shaun K Morris, MD, MPH
Description In this study, an acute respiratory infection (URTI and/or LRTI) has been clinically defined as: A) Upper respiratory tract infection (URTI) A new-onset illness consisting of at least two of the following clinical criteria at any time during a surveillance week: - Caregiver-reported cough; - Caregiver-reported rhinorrhea; - Caregiver-reported nasal congestion; and, - Measured axillary temperature greater than or equal to 37.5°C. B) Lower respiratory tract infection (LRTI) 1. New onset clinically-diagnosed LRTI: - Caregiver-reported cough AND/OR difficulty breathing during a surveillance week; AND, - Observed lower chest wall indrawing AND/OR elevated respiratory rate (60 breaths per minute or greater for infant up to 59 days of age, or 50 breaths per minute or greater for infant 60 days of age or older) 2. Hospitalized LRTI - Hospitalization with physician diagnosis of pneumonia or bronchiolitis
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.