Maternal Vitamin D for Acute Respiratory Infections in Infancy

Upper Respiratory Tract Infections Clinical Trial

— MDARI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388516
• Other study ID #: 1000039072-ARI
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2015
• Last updated: April 18, 2017
• Start date: December 2014
• Est. completion date: August 21, 2016

Study information

• Verified date: April 2017
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: August 21, 2016
• Est. primary completion date: August 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 26 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lower Respiratory Tract Infections
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Dietary Supplement:
• Vitamin D3

• Placebo

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangldesh	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI)		0 to 6 months
Secondary	ARI with microbiologically confirmed influenza A or B		0 to 6 months
Secondary	ARI with microbiologically confirmed RSV		0 to 6 months
Secondary	Clinical URTI and/or LRTI (i.e., no microbiological confirmation)		0 to 6 months
Secondary	Clinical URTI (i.e., no microbiological confirmation)		0 to 6 months
Secondary	Clinical LRTI (i.e., no microbiological confirmation)		0 to 6 months
Secondary	Quantitative S. pneumoniae nasal carriage density		0 to 6 months
Secondary	Pneumonia (non-severe) and severe pneumonia or very severe disease		2 to 6 months