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Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI)

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ClinicalTrials.gov Identifier: NCT02388516
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Daniel Roth, The Hospital for Sick Children

Brief 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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infections Lower Respiratory Tract Infections Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Phase 3

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : December 2014
Actual Primary Completion Date : August 21, 2016
Actual Study Completion Date : August 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Placebo Comparator: 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.
Dietary Supplement: Placebo
Experimental: Group B
Prenatal Period 4,200 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)
Dietary Supplement: Vitamin D3
Other Name: Cholecalciferol

Experimental: Group C
Prenatal Period 16,800 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)
Dietary Supplement: Vitamin D3
Other Name: Cholecalciferol

Experimental: Group D
Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)
Dietary Supplement: Vitamin D3
Other Name: Cholecalciferol

Experimental: Group E
Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 28,000 IU/week
Dietary Supplement: Vitamin D3
Other Name: Cholecalciferol




Primary Outcome Measures :
  1. Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) [ Time Frame: 0 to 6 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 26 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388516


Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research, Bangldesh
Dhaka, Bangladesh
Sponsors and Collaborators
The Hospital for Sick Children
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Shaun K Morris, MD, MPH The Hospital for Sick Children
Principal Investigator: Daniel Roth, MD, PhD The Hospital for Sick Children

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Roth, Clinician-Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02388516     History of Changes
Other Study ID Numbers: 1000039072-ARI
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Daniel Roth, The Hospital for Sick Children:
Bangladesh
Vitamin D
Acute Respiratory Infections
Infancy
Pregnancy

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents