Status:
UNKNOWN
Establishing Global Reference Values for Human Milk
Lead Sponsor:
USDA, Western Human Nutrition Research Center
Collaborating Sponsors:
University of Copenhagen
Medical Research Council Unit, The Gambia
Conditions:
Human Milk Nutrient Reference Values
Eligibility:
FEMALE
18-40 years
Brief Summary
The primary purpose of the proposed research is to establish Reference Values (RVs) for micronutrients (MN) and macronutrients in human milk. The investigators' research to date has revealed highly va...
Detailed Description
The investigators will collect breast milk samples at four visits, at 2-3 days after birth (colostrum) and at 1-3.4, 3.5-5.9, and 6-8.5 months of lactation from well-nourished mothers age ≥18 to ≤40 y...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2021
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03254329
Start Date
September 1 2017
End Date
November 30 2021
Last Update
July 7 2021
Active Locations (4)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Bangladesh, 1212
2
Federal University of Rio de Janeiro
Rio de Janeiro, Brazil, RJ21941-590
3
University of Copenhagen
Copenhagen, Frederiksberg, Denmark, 1958
4
Medical Research Council Gambia
Bakau, Kombo Saint Mary's, The Gambia