Skip to main content
OpenTrials
Completed

NCT Number: NCT02756026

Assessing the Quality of Breast Milk

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple micronutrient supplement (Nutri-Fem)

Dietary Supplement

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

Primary outcomes

  1. Change in Breast Milk Content of Cobalamin (Vitamin B12)

    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

Secondary outcomes

  1. Plasma Cobalamin (Vitamin B12)

    Time frame: Measured once in a fasting blood sample collected on day 2

    Vitamin B12 (pmol/L) is measured in plasma by automated immunoassay

  2. Plasma Folate

    Time frame: Measured once in a fasting blood sample collected on day 2

    Folate (nmol/L) is measured in plasma by automated immunoassay

  3. Change in Breast Milk Content of Thiamin

    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)

  4. Change in Breast Milk Content of Riboflavin

    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)

  5. Change in Breast Milk Content of Niacin

    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

  6. Change in Breast Milk Content of Vitamin B6

    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

  7. Change in Breast Milk Content of Vitamin A

    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

  8. Change in Breast Milk Content of Vitamin E

    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

  9. Change in Breast Milk Content of fat

    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.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2016
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.