Assessing the Quality of Breast Milk
Condition: Micronutrient Deficiency
Study type: Interventional

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.
    

Intervention name(s): Multiple micronutrient supplement (Nutri-Fem)
Intervention type(s): Dietary Supplement
Intervention description(s): Multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA).
Intervention MeSH terms: Micronutrients; Trace Elements
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Breast milk; mineral; vitamin