International Milk Composition (IMiC) Consortium

NCT05119166 | Active Not Recruiting DMC

• 2 other identifiers: HS23767H2020:161
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Create an international consortium of 4 birth cohorts in Tanzania, Pakistan, Burkina Faso and Canada (Field Site Partners), human milk scientists (Laboratory Partners), and data scientists and biostatisticians (Data Science Partners).

  The result of this outcome will be measured by the completion of governance structure and data sharing agreements with all partners.

  This outcome is anticipated to reach completion in December 2021.

• Create a centralized biorepository of human milk samples from the Field Site Partners, housed at the Manitoba Interdisciplinary Lactation Centre (MILC) at the University of Manitoba in Winnipeg, Manitoba, Canada.

  The result of this outcome will be measured by the completion of all milk samples collected, stored and catalogued at MILC.

  This outcome is anticipated to reach completion in April 2022.

• Create a standardized protocol for the comprehensive analysis of human milk composition using state-of-the-art methods in expert laboratories

  The result of this outcome will be measured by the completion of list of target milk components; agreements with laboratories; standard operating procedures (SOPs) for sample collection, processing, shipping and analysis.

  This outcome is anticipated to reach completion in December 2021.

• Create a harmonized dataset of human milk composition and relevant maternal, infant and environmental data from 1000 dyads

  The result of this outcome will be measured by complete, clean, accessible, dataset meeting FAIR (Findable, Accessible, Interoperable, Reusable: www.gofair.org) Guiding Principles, including milk composition data and relevant metadata for all included dyads.

  This outcome is anticipated to reach completion in October 2023.

• Create an integrated analysis of this dataset

  Create an integrated analysis of this dataset, addressing research questions such as: * What are the ranges and distributions of analytes in human milk in different geographic settings? * How are various components in human milk correlated with each other? * How is breast milk composition influenced by maternal, environmental and sociodemographic factors? The result of this outcome will be measured by answering the above research questions, compiled in reports and open access academic publications

  This outcome is anticipated to reach completion in October 2023.

Secondary Outcomes (1)

• A secondary objective of IMiC will be to support data integration across sites to answer important questions.

  This outcome is anticipated to reach completion in October 2023.

Study Arms (4)

Canadian Healthy Infant Longitudinal Development (CHILD) Cohort Study

The CHILD Cohort Study is a prospective longitudinal birth cohort study. It is an observational study of healthy term infants in Canada (Vancouver, Edmonton, Manitoba, Toronto). The birth years were between 2009-2012, and is currently at the 8 year postnatal follow up phase. IMiC will receive 400 breast milk samples from 400 dyads (100/site) that were taken between 3-4 months postnatal.

The Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Study

(NCT03268902). ELICIT is a randomized controlled trial (RCT) evaluating the efficacy of antimicrobials and nicotinamide in increasing growth in the setting of Rural Tanzania. It is factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis to infants. IMiC will receive 400 breast milk samples from 200 dyads, 2 samples per dyad taken at 1 \& 5 months postnatal.

Dietary Supplement: Vitamin B3; Biological: Azithromycin

VITAL Pakistan

Two Randomized Controlled Trials: Mumta (Nutritional support for lactating women with or without azithromycin)PW - NCT04012177 and MumtaLW - NCT03564652 VITAL is a community-based, randomized control, assessor blinded trial in peri-urban settings of Karachi, Pakistan to study the impact of Lipid-based Nutritional Supplement for Pregnant and Lactating women which is balanced energy-protein (BEP) dietary supplement, a locally produced ready-to-use nutritional product for lactating women (LW) and single prophylaxis dose of Azithromycin for infants, on growth of infants over the period of six months since birth compared to current standard of care. IMiC will receive 600 breast milk samples from 200 dyads, 3 samples per dyad taken at 0-1, 1-2 \& 2-3 months.

Biological: Azithromycin; Dietary Supplement: Fortified food supplement

Micronutriments pour la Santé de la Mère et de l'Enfant (MISAME)-3 study (NCT03533712)

MISAME-3 is a randomized controlled clinical trial in the setting of Rural Burkina Faso. A BEP supplement provides less than 25% of protein of the total energy content, and includes different vitamins and minerals. The first part of an exploratory study will determine which type of BEP supplement (bar, drink, biscuit, soup or paste) is most accepted by pregnant women. Subsequently, two products will be tested for longer-term acceptability and at-home use (phase 1). The effect of the most suitable supplement will be tested in a controlled clinical trial (phase 2). The intervention group will receive the dietary supplement during pregnancy and/or lactation, while the control group complies with the standard iron and folic acid tablets following the national guidelines. IMiC will receive 600 breast milk samples from 200 dyads, 3 samples per dyad taken at 0-1, 1-2 \& 3-4 months.

Dietary Supplement: Fortified food supplement

Interventions

Vitamin B3 DIETARY_SUPPLEMENT

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

Also known as: Nicotinamide

The Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Study

Azithromycin BIOLOGICAL

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.

The Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Study; VITAL Pakistan

Fortified food supplement DIETARY_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).

Micronutriments pour la Santé de la Mère et de l'Enfant (MISAME)-3 study (NCT03533712); VITAL Pakistan

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CHILD Study: observational study of healthy term infants from Canada, Multi-ethnic (\~70% Caucasian; 30% others: Asian, First Nations, Black, other) ELICIT Study: factorial RCT study design, cohorts from Haydom, Tanzania, predominantly of Black and East African descent VITAL Study: 3-arm RCT study design, cohorts from Karachi, Pakistan, predominantly of Asian descent MISAMEIII Study: 2x2 cross-over RCT study design, cohorts from Hounde District, Burkina Faso, predominantly of Black and West African descent

You may qualify if:

• CHILD Study: Full term healthy infant; singleton pregnancy; English literary
• ELICIT Study: Adult mothers, child \<14 days, lives within 25km of Haydom
• VITAL Study: Lactating, biological mothers
• MISAMEIII Study: Confirmed (pregnancy test/ultrasound) pregnant women 15-40 years old, informed consent, self, parents or husband (for minors; assent).

You may not qualify if:

• CHILD Study: IVF; congenital abnormality; preterm delivery
• ELICIT Study: Multiple gestation, birth defects/neonatal illness, weight \<1.5g, no intention to breastfeed, will move from area within 18 months
• VITAL Study: Use of any ointments or topical solutions immediately prior to sampling, non-consent
• MISAMEIII Study: Peanut allergy, gestational age \<20weeks, women who will not deliver babies in or live in study area by delivery date.

Sponsors & Collaborators

• University of Manitoba: lead
• Bill and Melinda Gates Foundation: collaborator
• Stanford University: collaborator
• The University of Western Australia: collaborator
• University of Idaho: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Johns Hopkins University: collaborator
• Cedars-Sinai Medical Center: collaborator
• Sapient Bioanalytics: collaborator
• University of California, Davis: collaborator
• University of California, San Diego: collaborator
• University of Virginia: collaborator
• Aga Khan University: collaborator
• University Ghent: collaborator
• University of California, Berkeley: collaborator
• University Health Network, Toronto: collaborator
• USDA Beltsville Human Nutrition Research Center: collaborator
• Antigen Discovery Inc: collaborator
• USDA, Western Human Nutrition Research Center: collaborator

Study Sites (1)

Manitoba Interdisciplinary Lactation Centre (MILC)

Winnipeg, Manitoba, R3E3P4, Canada

Location

Related Publications (26)

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Biospecimen

Retention: SAMPLES WITH DNA

Human Breast Milk Samples

MeSH Terms

Interventions

Niacinamide; Azithromycin

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Meghan B Azad

  University of Manitoba, CHILD Cohort Study

  PRINCIPAL INVESTIGATOR

• Estomih Mduma

  Haydom Lutheran Hospital, ELICIT Trial

  STUDY DIRECTOR

• Fyezah Jehan

  Aga Khan University Pakistan, VITAL Trial

  PRINCIPAL INVESTIGATOR

• Laeticia Celine Toe

  Institut de Recherche en Science de la Santa, MISAMEIII Trial

  STUDY DIRECTOR

• PJ Subbarao

  SickKids, CHILD Study

  STUDY DIRECTOR

• Yasir Shafiq

  Aga Khan University Pakistan, VITAL Trial

  PRINCIPAL INVESTIGATOR

• Mark D DeBoer

  University of Virginia, VITAL Trial

  PRINCIPAL INVESTIGATOR

• Patrick Kolsteren

  Ghent University, MISAMEIII Trial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 15, 2021
• Study Start: November 17, 2019
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Embargo period of 12 months followed by full open access
• Access Criteria: Embargo period of 12 months followed by full open access

Locations

CA (1)