Clinical Trial: Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age Bangladeshi Infants
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Longitudinal Studies of Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age, Predominantly Breast Fed, Bangladeshi Infants
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.
Detailed Summary:
The International Atomic Energy Agency (IAEA) has reviewed published literature to collect information for its Coordinated Research Project (CRP) on Zinc Nutrition During Early Life , and observed that there is limited information on: 1) the concentration of zinc in breast milk of mothers in lower income countries at different times post-partum; 2) the total amount of zinc transferred from mothers to infants at different ages in these settings, and 3) zinc transfer from mother to infant born with appropriate-for-gestational-age (AGA) and small-for-gestational-age (SGA). Therefore, IAEA has planned to assist local scientists to collect such information from selected countries. The International Zinc Nutrition Consultative Group (IZiNCG) has identified Bangladesh as a country with high risk of zinc deficiency (IZiNCG, 2004), where the rate of SGA infants is >30% - one of the highest in the world (de Onis, 1998). Thus, Bangladesh is an appropriate candidate country to participate in this CRP.
This study will enroll 50 healthy, full-term, newborn infants (>37 weeks gestational age by ultrasound) and their mothers if they plan to breast-feed exclusively for at least 4 months and also to continue breast feeding for at least 12 months. The infants will be examined, weighed and measured within 48 hours of birth, half of whom will be AGA (BW>2800g) and the other half SGA (BW<2500g). Infants with any acute or chronic illnesses, or congenital anomalies will not be eligible. Any mother with toxaemia, pregnancy-induced hypertension, multiple pregnancies, previously diagnosed as positive for HIV/hepatitis B infections, or habituated to smoking or alcohol consumption will also be excluded. The participants will be recruited from Nandipara, Dhaka, an urban community where the ICDDRB has ongoing clinical study facilities.
Each
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Current Primary Outcome: Amount of zinc transferred through breast milk [ Time Frame: at 4, 12 and 24 weeks after delivery of the infants ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Plasma zinc content of both the mother and the infant [ Time Frame: at 4, 12 and 24 weeks after the delivery of the infants ]
Original Secondary Outcome: Same as current
Information By: International Centre for Diarrhoeal Disease Research, Bangladesh
Dates:
Date Received: November 4, 2012
Date Started: July 2006
Date Completion:
Last Updated: November 19, 2012
Last Verified: November 2012