Establishing Global Reference Values for Human Milk

• Register: ClinicalTrials.gov
• Last refreshed on: 12 July 2021
• Main ID: NCT03254329
• Date of registration: 03/08/2017
• Prospective Registration: Yes
• Primary sponsor: USDA, Western Human Nutrition Research Center
• Public title: Establishing Global Reference Values for Human Milk MILQ
• Scientific title: Establishing Global Reference Values for Human Milk Composition in a Multi-Center Collaborative Study
• Date of first enrolment: September 1, 2017
• Target sample size: 2000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03254329
• Study type: Observational

Countries of recruitment

Bangladesh, Brazil, Denmark, Gambia

Contacts

• Name: Lindsay H Allen, PhD

• Name: Lindsay H Allen, PhD
• Affiliation: USDA/WHNRC

Key inclusion & exclusion criteria

Inclusion Criteria for Mother

- No vitamin-mineral supplements during third trimester of pregnancy or during lactation
except for iron + folic acid, also vitamin D and Ca in Denmark.

- Low habitual intake of highly-fortified foods (iodized salt excepted).

- No relevant past or current medical problems including gestational diabetes or
pre-eclampsia.

- Singleton delivery, not preterm.

- BMI =18.5 to <30.0 kg/m2, height =150 cm.

- Mid-upper arm circumference (MUAC) =23 and =33 cm in pregnancy

- Consuming a nutritionally adequate diet i.e. not vegan or macrobiotic, =5 food
groups/d each =15g. At screening this information will be collected with a
locally-appropriate and validated food frequency questionnaire.

- Non-anemic in pregnancy (Hb >100 g/L)

- Alcohol intake =5 units (50 mL pure alcohol)/week.

- Non-smoker.

Inclusion Criteria for Infant

- Birth weight 2500-4200 g, 37-42 weeks of gestation.

- No congenital malformations that interfere with feeding or growth and development.

Exclusion Criteria at 1 to 3.4 Months Postpartum

- Cessation of or non-exclusive breastfeeding.

- Serious maternal illness.

- Infant length-for-age, weight-for-age or weight-for-length < -2 Z.

Exclusion criteria 3.5 to 8.5 months postpartum

- Cessation of breastfeeding.

- Serious maternal illness.

- Infant length-for-age, weight-for-age or weight-for-length < -2 Z.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Human Milk Nutrient Reference Values

Intervention(s)

Other: Assessment of human milk nutrient composition

Primary Outcome(s)

Change in vitamin and mineral concentrations in human breast milk [Time Frame: Breast milk samples collected 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Secondary Outcome(s)

Maternal Hemoglobin A1c (HbA1c) [Time Frame: Measured once at gestational week 28-30]

Maternal markers of insulin sensitivity [Time Frame: Measured once at gestational week 28-30]

Infant development [Time Frame: 6-8.5 months]

Infant nutrient intake [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months]

Change in infant microbiome [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months]

Infant weight [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months]

Maternal height [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Infant body composition [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months]

Milk iodine [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Change in maternal microbiome [Time Frame: Collected at gestational week 28-40, and 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Milk volume [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Infant morbidity [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months]

Maternal body composition [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Maternal inflammatory markers [Time Frame: Measured once at gestational week 28-30]

Maternal nutrient intake [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Maternal Glucose Tolerance [Time Frame: Measured once at gestational week 28-30]

Micronutrient status of mothers and infants [Time Frame: Blood and urine samples surveyed at 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Variation in other constituents of human breast milk [Time Frame: Breast milk samples collected at 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Infant motor development [Time Frame: 3.5-5.9 and 6-8.5 months]

Maternal and infant iodine status [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Infant dietary habits [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months]

Infant growth [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Maternal body mass index [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Maternal lipid panel [Time Frame: Measured once at gestational week 28-30]

Infant length [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months]

Maternal weight [Time Frame: 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]

Maternal nutrient intake during pregnancy [Time Frame: Measured during gestational week 35-37]

Secondary ID(s)

MILQ

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical Research Council Unit, The Gambia

Bill and Melinda Gates Foundation

Universidade Federal do Rio de Janeiro

University of Copenhagen

International Centre for Diarrhoeal Disease Research, Bangladesh