International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Bangladesh
NCT Number: NCT02756026
The purpose of the study is to establish a protocol for collecting representative samples of breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN) supplementation on milk MN concentrations. The investigators will determine which breastfeeding episode during the 24 hour period best represents the maternal status; and within the episode whether fore, mid or hind milk samples be collected in future studies.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Dhaka, Bangladesh
Mother-infant pairs were recruited in the peri urban area of Dhaka, Bangladesh to participate in a protocol development study at International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). The participants will spend 5 days in a metabolic unit of icddr,b and the procedures are as follows:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA).
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Vitamin B12 (ng/L) is measured in breast milk by quantitative immunoassay
Time frame: Measured once in a fasting blood sample collected on day 2
Vitamin B12 (pmol/L) is measured in plasma by automated immunoassay
Time frame: Measured once in a fasting blood sample collected on day 2
Folate (nmol/L) is measured in plasma by automated immunoassay
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Thiamin in breast milk (ug/L) is measured as Thiamin, Thiamin-monophosphate, and Thiamin-pyrophosphate by high performance liquid chromatography (HPLC)
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Riboflavin in breast milk (ug/L) is measured as Riboflavin and Flavin adenine dinucleotide by ultra-performance liquid chromatography followed by tandem mass spectrometry (UPLC-MS/MS)
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Niacin in breast milk (ug/L) is measured as Nicotinamide by UPLC-MS/MS
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Vitamin B6 in breast milk (ug/L) is measured as Pyridoxal by UPLC-MS/MS
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Vitamin A in breast milk (nmol/L) is measured as retinol and beta-carotene by HPLC
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Vitamin E in breast milk (nmol/L) is measured as alpha-tocopherol and gamma-tocopherol by HPLC
Time frame: Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk
Fat in breast milk (g/L) is measured using a creamatocrit.
USDA, Western Human Nutrition Research Center
Fed
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