International Milk Composition (IMiC) Consortium

Summary

The IMiC Consortium will analyze milk from 1000 mother-infant dyads across 4 diverse settings (Tanzania, Pakistan, Burkina Faso and Canada). Samples will be stored centrally at the Manitoba Interdisciplinary Lactation Centre (MILC) biorepository and distributed to multiple laboratories for analysis of macronutrients, micronutrients, oligosaccharides, growth factors, immunoglobulins, cytokines, metabolites and microbes. Data will be harmonized and stored in a central database, and diverse statistical methods will be applied for data integration and analysis.

Conditions

• Infant Growth
• Maternal Health
• Infant Nutrition

Interventions

DIETARY_SUPPLEMENT

Vitamin B3

ELICIT Study: Factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis (Azithromycin) to infants.

BIOLOGICAL

Azithromycin

ELICIT Study: Factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis (Azithromycin) to infants. VITAL Pakistan Study: 3-arm RCT of fortified food supplement (protein energy) during lactation, with or without azithromycin prophylaxis for infant.

DIETARY_SUPPLEMENT

Fortified food supplement

VITAL Study: 3-arm RCT of fortified food supplement (protein energy) during lactation, with or without azithromycin prophylaxis for infant. MISAMEIII Study: 2x2 cross-over efficacy RCT of fortified food supplement (folic acid/iron +/- peanut spread) during pregnancy and/or lactation; unmasked (open label).

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Stanford University

  collaborator OTHER

• The University of Western Australia

  collaborator OTHER

• University of Idaho

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Sapient Bioanalytics

  collaborator UNKNOWN

• University of California, Davis

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• University Ghent

  collaborator OTHER

• University of California, Berkeley

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• USDA Beltsville Human Nutrition Research Center

  collaborator FED

• Antigen Discovery Inc

  collaborator UNKNOWN

• USDA, Western Human Nutrition Research Center

  collaborator FED

• University of Manitoba

  lead OTHER

Principal Investigators

• Meghan B Azad · University of Manitoba, CHILD Cohort Study

• Estomih Mduma · Haydom Lutheran Hospital, ELICIT Trial

• Fyezah Jehan · Aga Khan University Pakistan, VITAL Trial

• Laeticia Celine Toe · Institut de Recherche en Science de la Santa, MISAMEIII Trial

• PJ Subbarao · SickKids, CHILD Study

• Yasir Shafiq · Aga Khan University Pakistan, VITAL Trial

• Mark D DeBoer · University of Virginia, VITAL Trial

• Patrick Kolsteren · Ghent University, MISAMEIII Trial

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-17

Primary Completion

2026-10-30

Completion

2026-10-30

Countries

• Canada

Study Locations