deltatrials
Completed OBSERVATIONAL NCT01140256

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

Updated 5 times since 2017 Last updated: Jun 8, 2010 Started: Jan 31, 2007 Completion: Jul 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jan 2021 · 33 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Jan 2021 — Jul 2024 [monthly]

    Completed

  4. Apr 2018 — Jan 2021 [monthly]

    Completed

    Phase: NANone

  5. 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

Sponsor contact:
  • Aga Khan University
  • International Atomic Energy Agency
  • University of Colorado, Denver
Data source: Aga Khan University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations