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Completed

NCT Number: NCT02388516

Maternal Vitamin D for Acute Respiratory Infections in Infancy

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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Key information

Age range

1 day–26 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

International Centre for Diarrhoeal Disease Research, Bangldesh

Dhaka, Bangladesh

About this study

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)

  • 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)
  • Hospitalized LRTI
  • Hospitalization with physician diagnosis of pneumonia or bronchiolitis

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

Other names: Cholecalciferol

Placebo

Dietary Supplement

Primary outcomes

  1. Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI)

    Time frame: 0 to 6 months

Secondary outcomes

  1. ARI with microbiologically confirmed influenza A or B

    Time frame: 0 to 6 months

  2. ARI with microbiologically confirmed RSV

    Time frame: 0 to 6 months

  3. Clinical URTI and/or LRTI (i.e., no microbiological confirmation)

    Time frame: 0 to 6 months

  4. Clinical URTI (i.e., no microbiological confirmation)

    Time frame: 0 to 6 months

  5. Clinical LRTI (i.e., no microbiological confirmation)

    Time frame: 0 to 6 months

  6. Quantitative S. pneumoniae nasal carriage density

    Time frame: 0 to 6 months

  7. Pneumonia (non-severe) and severe pneumonia or very severe disease

    Time frame: 2 to 6 months

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study 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

Acronym: MDARI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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