Assessing the Quality of Breast Milk

Micronutrient Deficiency Clinical Trial

Official title:

Assessing the Quality of Breast Milk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756026
• Other study ID #: BMQ
• Secondary ID: 429296-1
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: April 26, 2016
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2016
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Micronutrient Deficiency

Intervention

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

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Breast Milk Content of Cobalamin (Vitamin B12)	Vitamin B12 (ng/L) is measured in breast milk by quantitative immunoassay	Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk	No
Secondary	Plasma Cobalamin (Vitamin B12)	Vitamin B12 (pmol/L) is measured in plasma by automated immunoassay	Measured once in a fasting blood sample collected on day 2	No
Secondary	Plasma Folate	Folate (nmol/L) is measured in plasma by automated immunoassay	Measured once in a fasting blood sample collected on day 2	No
Secondary	Change in Breast Milk Content of Thiamin	Thiamin in breast milk (ug/L) is measured as Thiamin, Thiamin-monophosphate, and Thiamin-pyrophosphate by high performance liquid chromatography (HPLC)	Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk	No
Secondary	Change in Breast Milk Content of Riboflavin	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)	Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk	No
Secondary	Change in Breast Milk Content of Niacin	Niacin in breast milk (ug/L) is measured as Nicotinamide by UPLC-MS/MS	Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk	No
Secondary	Change in Breast Milk Content of Vitamin B6	Vitamin B6 in breast milk (ug/L) is measured as Pyridoxal by UPLC-MS/MS	Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk	No
Secondary	Change in Breast Milk Content of Vitamin A	Vitamin A in breast milk (nmol/L) is measured as retinol and beta-carotene by HPLC	Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk	No
Secondary	Change in Breast Milk Content of Vitamin E	Vitamin E in breast milk (nmol/L) is measured as alpha-tocopherol and gamma-tocopherol by HPLC	Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk	No
Secondary	Change in Breast Milk Content of fat	Fat in breast milk (g/L) is measured using a creamatocrit.	Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk	No