Maternal Vitamin D for Acute Respiratory Infections in Infancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-08-21

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Upper Respiratory Tract Infections Lower Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

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.

Group Type PLACEBO_COMPARATOR