Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age Bangladeshi Infants

NCT01728766 | Completed

• 1 other identifier: 2006-035
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Data collected from this study will provide information on the breast milk zinc concentration, maternal and infant zinc status, and transfer of zinc from mothers breast milk to infants during first six months of life.

Conditions

Small for Gestational Age at Delivery; Post-term Infant, Not Heavy-for-dates

Keywords

Breast milk zinc transfer; Bangladeshi infants; appropriate-for-gestational-age; small-for-gestational-age; plasma zinc

Outcome Measures

Primary Outcomes (1)

• Amount of zinc transferred through breast milk

  During each round of study, a milk sample was collected during the visit to icddr,b on study day 1 and 5. On each occasion, the breast was cleansed with soap and water and rinsed with copious amounts of deionized water. The milk sample was then collected \~2-3 minutes after the feeding was initiated by momentarily removing the infant from the breast, so the study assistant could manually express 5-10 mL milk into a zinc-free beaker. The milk sample was then transferred to a plastic screw cap vial and transported to the laboratory, as described above for the saliva samples. The milk zinc concentration was measured by atomic absorption spectrometer (AAS, AA6501S, Shimadzu, Kyoto, Japan). The total zinc transfer from mother to infant was calculated as the product of the mean daily milk volume, as determined from the deuterium tracer studies, and the mean milk zinc concentration on the corresponding milk collection days.

  at 4, 12 and 24 weeks after delivery of the infants

Secondary Outcomes (1)

• Plasma zinc content of both the mother and the infant

  at 4, 12 and 24 weeks after the delivery of the infants

Study Arms (1)

Infants under-6 months and their mothers

Small for gestational age at delivery. Post-term Infant, Not Heavy-for-dates.

Other: Small for gestational age at delivery; Other: Post-term Infant, Not Heavy-for-dates

Interventions

Small for gestational age at delivery OTHER

Small for gestational age at delivery. gestational age at \>37 weeks by and birth weight \<2500 g

Also known as: Small-for-Gestational Age (SGA)

Infants under-6 months and their mothers

Post-term Infant, Not Heavy-for-dates OTHER

Appropriate for gestational age at delivery. Gestational age at \>37 weeks and birth weight \>2800 g

Also known as: Appropriate-for-gestational age (AGA)

Infants under-6 months and their mothers

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The participants were 46 mothers and their term infants, 20 of whom were classified as appropriate for gestational age (AGA, birth weight \>2800 g at ≥37 weeks of gestation) and 26 of whom were classified as small for gestational age (SGA, birth weight \<2500 g at ≥37 weeks of gestation). Gestational age was assessed by ultrasonography at \~32 weeks of gestation. Only mothers who were planning to breast feed exclusively for at least four months were included in the study. Mothers with pregnancy-induced hypertension, multiple pregnancies, known HIV or hepatitis B infection, or use of tobacco products or alcohol were excluded from the study, as were infants with congenital abnormalities, chronic infections, or acute illnesses at the time of enrollment.

You may qualify if:

• AGA, birth weight \>2800 g at ≥37 weeks of gestation
• SGA, birth weight \<2500 g at ≥37 weeks of gestation

You may not qualify if:

• Other than the above birth weight
• Any congenital anomalies abnormalities, chronic infections as were infants with c, or acute illnesses at the time of enrollment
• Mothers with pregnancy-induced hypertension, multiple pregnancies, known HIV or hepatitis B infection, or use of tobacco products or alcohol were excluded from the study,

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• University of California, Davis: collaborator

Study Sites (1)

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

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Islam MM, Brown KH. Zinc transferred through breast milk does not differ between appropriate- and small-for-gestational-age, predominantly breast-fed Bangladeshi infants. J Nutr. 2014 May;144(5):771-6. doi: 10.3945/jn.113.189308. Epub 2014 Mar 5.

  PMID: 24598881 DERIVED

Biospecimen

Retention: NONE RETAINED

Breast milk Plasma

Study Officials

• Dr M Munirul Islam, MBBS, PhD

  Associate Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2012
• First Posted: November 20, 2012
• Study Start: July 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 2, 2017

Record last verified: 2012-11

Locations

BA (1)