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Assessing the Quality of Breast Milk

Assessing the Quality of Breast Milk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02756026
Enrollment
19
Registered
2016-04-29
Start date
2013-09-30
Completion date
2014-02-28
Last updated
2016-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Micronutrient Deficiency

Keywords

Breast milk, mineral, vitamin

Brief summary

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.

Detailed description

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: * On day 1, mother-infant pairs will come to the facility, consume their evening meal and spend the night. * On day 2, the mothers will be asked to breastfeed their infant from one breast for as long as the infant is interested. An electric breast pump will be placed simultaneously on the other breast for a Full Milk (FM) collection. For the duration of the study the same breast will be used for feeding the infant the other breast will be used for the FM collection. Three separate aliquots of fore milk (up to 1 minute), mid (50 mL), and hind (until the breast is empty) milk will be collected by a special funnel attached to the breast pump. A 5 mL aliquot of BM will be removed from each the 3 aliquots for creamatocrit measurement and later vitamin and mineral determinations. The remainder of the pumped breast milk will be pooled and given to the mother to feed to her infant. A fasting blood sample (7 mL) will be obtained by venipuncture to measure maternal MN status. A breakfast meal will be served to the mother after the first feeding and the blood draw. The mother will be asked to refrain from breastfeeding her infant for the next 2-3 hours then the collection procedure will be repeated until the mother goes to sleep at night, and at any time during the night that the mother wakes to feed her infant. The meals for breakfast, lunch and dinner will be low in micronutrients. * On day 3, the mothers will be given one commercial multiple micronutrient supplement tablet containing the Recommended Dietary Intake (RDA). Milk collection procedures will be repeated the same as on day 2. The meals for breakfast, lunch and dinner will be low in micronutrients. Between breast milk collections the staff will collect maternal and infant anthropometry data, and administer Food Frequency (FF) and morbidity questionnaires. * On day 4, the mothers will be given two commercial multiple micronutrient supplement tablets containing the Recommended Dietary Intake (RDA). Milk collection procedures will be repeated the same as on day 3. The meals for breakfast, lunch and dinner will be low in micronutrients. * On day 5, the study will end with a final collection of BM in the morning and the study participants will be discharged from the facility.

Interventions

DIETARY_SUPPLEMENTMultiple micronutrient supplement (Nutri-Fem)

Multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA).

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
USDA, Western Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI \>18.5 Healthy * In the 2nd to 4th month of lactation and breastfeeding ≥12 times/d * Breast-feeding only one infant * Non-pregnant * Willing to spend 4 days and nights at the metabolic unit * Willing to perform the procedures of BM collection using the breast pump.

Exclusion criteria

* Severe anemia (Hb \<90 g/L) by HemoCue * Currently taking micronutrient supplements * Current pregnancy * Current illness * Current Mastitis

Design outcomes

Primary

MeasureTime frameDescription
Change in Breast Milk Content of Cobalamin (Vitamin B12)Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milkVitamin B12 (ng/L) is measured in breast milk by quantitative immunoassay

Secondary

MeasureTime frameDescription
Plasma FolateMeasured once in a fasting blood sample collected on day 2Folate (nmol/L) is measured in plasma by automated immunoassay
Change in Breast Milk Content of ThiaminBreast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milkThiamin in breast milk (ug/L) is measured as Thiamin, Thiamin-monophosphate, and Thiamin-pyrophosphate by high performance liquid chromatography (HPLC)
Change in Breast Milk Content of RiboflavinBreast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milkRiboflavin 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)
Change in Breast Milk Content of NiacinBreast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milkNiacin in breast milk (ug/L) is measured as Nicotinamide by UPLC-MS/MS
Plasma Cobalamin (Vitamin B12)Measured once in a fasting blood sample collected on day 2Vitamin B12 (pmol/L) is measured in plasma by automated immunoassay
Change in Breast Milk Content of Vitamin ABreast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milkVitamin A in breast milk (nmol/L) is measured as retinol and beta-carotene by HPLC
Change in Breast Milk Content of Vitamin EBreast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milkVitamin E in breast milk (nmol/L) is measured as alpha-tocopherol and gamma-tocopherol by HPLC
Change in Breast Milk Content of fatBreast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milkFat in breast milk (g/L) is measured using a creamatocrit.
Change in Breast Milk Content of Vitamin B6Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milkVitamin B6 in breast milk (ug/L) is measured as Pyridoxal by UPLC-MS/MS

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026