Longitudinal Zinc Intakes and Exchangeable Zinc Pool Sizes in Breastfed Small for Gestational Age vs Appropriate for Gestational Age Infants in Pakistan (EZP)
Sponsor: Aga Khan University
A observational or N/A phase clinical study on Gestational Age and Micronutrients, this trial is completed. The trial is conducted by Aga Khan University and has accumulated 5 data snapshots since 2007. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Scientific Background: Large-scale zinc supplementation studies have demonstrated highly significant positive effects on growth, morbidity and mortality in infants who are born small for gestational age (SGA). This suggests these infants may have higher postnatal requirements compared to appropriate for gestational age (AGA) infants, possibly due to inadequate zinc intake from breast milk due either to lower volume or to differences in milk zinc concentrations from mothers of SGA compared to AGA infants. Alternatively, SGA infants may have lower zinc stores at birth, which may reflect a greater postnatal requirement for optimal zinc status. It is thus possible that the zinc requirements of the SGA infant exceed the zinc intake that can be achieved from exclusive breastfeeding, which is recommended for the first 6 mo of life. Estimated rates of infants born with intrauterine growth retardation, including SGA, are 25-40% of all births in south Asia (Bhutta - 2004a). Scientific Scope of the Project (Scientific problems to be addressed with overall and specific objectives): The overall objective of this project is to compare zinc intake from human milk and other fluids and complementary foods in SGA and AGA infants through the first 12 mo of life; growth for each group...
Scientific Background:
Large-scale zinc supplementation studies have demonstrated highly significant positive effects on growth, morbidity and mortality in infants who are born small for gestational age (SGA). This suggests these infants may have higher postnatal requirements compared to appropriate for gestational age (AGA) infants, possibly due to inadequate zinc intake from breast milk due either to lower volume or to differences in milk zinc concentrations from mothers of SGA compared to AGA infants. Alternatively, SGA infants may have lower zinc stores at birth, which may reflect a greater postnatal requirement for optimal zinc status. It is thus possible that the zinc requirements of the SGA infant exceed the zinc intake that can be achieved from exclusive breastfeeding, which is recommended for the first 6 mo of life. Estimated rates of infants born with intrauterine growth retardation, including SGA, are 25-40% of all births in south Asia (Bhutta - 2004a).
Scientific Scope of the Project (Scientific problems to be addressed with overall and specific objectives):
The overall objective of this project is to compare zinc intake from human milk and other fluids and complementary foods in SGA and AGA infants through the first 12 mo of life; growth for each group will also be monitored. A secondary goal is to compare the size of the exchangeable zinc pool in SGA and AGA infants at birth and at 6 mo, the period of recommended exclusive breastfeeding.
Specific Aims:
1. Compare longitudinal zinc intake by measuring milk zinc concentrations and volume of intake of breast milk between SGA and AGA infants through first 12 mo. 2. Compare post-natal growth rates for SGA and AGA infants through the first 12 mo of life in relation to zinc intake. 3. Compare size of exchangeable zinc pool (EZP) at birth and at 6 mo of age between SGA and AGA infants.
Expected Outcomes:
Expected outcomes include longitudinal data from SGA and AGA infants during the first year of life, including human milk intake, zinc concentrations in human milk, zinc intake from human milk, estimated intake of non-milk fluids and complementary foods, anthropometric measurements (length, weight, and head circumference), and size of exchangeable zinc pool; cross-sectional data on plasma zinc, ferritin and hemoglobin at 6 mo will also be obtained. These outcomes will all be compared between SGA and AGA infants. Relationships among variables will also be examined, including relationship of zinc intake and size of EZP to observed growth outcomes.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
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Jan 2021 — Jul 2024 [monthly]
Completed
-
Apr 2018 — Jan 2021 [monthly]
Completed
Phase: NA → None
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Jan 2017 — Apr 2018 [monthly]
Completed NA
First recorded
Jan 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Aga Khan University
- International Atomic Energy Agency
- University of Colorado, Denver
For direct contact, visit the study record on ClinicalTrials.gov .