Maternal Vitamin D for Acute Respiratory Infections in Infancy

NCT02388516 | Completed Phase 3 DMC

• 1 other identifier: 1000039072-ARI
• Study Type: interventional
• Target: 1,214
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infections; Lower Respiratory Tract Infections

Keywords

Bangladesh; Vitamin D; Acute Respiratory Infections; Infancy; Pregnancy

Outcome Measures

Primary Outcomes (1)

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

  0 to 6 months

Secondary Outcomes (7)

• ARI with microbiologically confirmed influenza A or B

  0 to 6 months

• ARI with microbiologically confirmed RSV

  0 to 6 months

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

  0 to 6 months

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

  0 to 6 months

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

  0 to 6 months

Study Arms (5)

Group A

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.

Dietary Supplement: Placebo

Group B

EXPERIMENTAL

Prenatal Period 4,200 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)

Dietary Supplement: Vitamin D3

Group C

EXPERIMENTAL

Prenatal Period 16,800 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)

Dietary Supplement: Vitamin D3

Group D

EXPERIMENTAL

Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 0 IU/week (placebo)

Dietary Supplement: Vitamin D3

Group E

EXPERIMENTAL

Prenatal Period 28,000 IU/week of vitamin D3; Postpartum Period 28,000 IU/week

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Also known as: Cholecalciferol

Group B; Group C; Group D; Group E

Placebo DIETARY_SUPPLEMENT

Group A

Eligibility Criteria

• Age: 1 Day - 26 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants born to women enrolled in the MDIG trial (NCT01924013).
• At least 18 years of age
• 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

You may not qualify if:

• Mother withdrawn from MDIG trial prior to delivery
• Failure to provide consent for participation in sub-study

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangldesh

Dhaka, Bangladesh

Location

Related Publications (2)

• Taghivand M, Pell LG, Rahman MZ, Mahmud AA, Ohuma EO, Pullangyeum EM, Ahmed T, Hamer DH, Zlotkin SH, Gubbay JB, Morris SK, Roth DE. Effect of maternal vitamin D supplementation on nasal pneumococcal acquisition, carriage dynamics and carriage density in infants in Dhaka, Bangladesh. BMC Infect Dis. 2022 Jan 13;22(1):52. doi: 10.1186/s12879-022-07032-y.

  PMID: 35026987 DERIVED

• Morris SK, Pell LG, Rahman MZ, Dimitris MC, Mahmud A, Islam MM, Ahmed T, Pullenayegum E, Kashem T, Shanta SS, Gubbay J, Papp E, Science M, Zlotkin S, Roth DE. Maternal vitamin D supplementation during pregnancy and lactation to prevent acute respiratory infections in infancy in Dhaka, Bangladesh (MDARI trial): protocol for a prospective cohort study nested within a randomized controlled trial. BMC Pregnancy Childbirth. 2016 Oct 13;16(1):309. doi: 10.1186/s12884-016-1103-9.

  PMID: 27737646 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Shaun K Morris, MD, MPH

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Daniel Roth, MD, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: December 1, 2014
• Primary Completion: August 21, 2016
• Study Completion: August 21, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

BA (1)