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Longitudinal Zinc Intakes and Exchangeable Zinc Pool Sizes in Breastfed Small for Gestational Age vs Appropriate for Gestational Age Infants in Pakistan

NCT01140256 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2010-06-09

No results posted yet for this study

Summary

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. The exchangeable zinc pool (EZP) is defined as the estimate of the total size of the combined pools of zinc that exchange with zinc in plasma within approximately 2-3 days and may also differ between SGA and AGA infants.

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.

Hypotheses:

1. Zinc concentrations in human milk will not be significantly different at any stage of lactation between mothers of SGA infants and mothers of AGA infants.
2. The volume of breast milk intake relative to body weight will be similar between SGA and AGA infants, but the total intake will be lower in SGA infants.
3. Linear growth rates, rate of weight gain, and rate of growth in head circumference will be significantly lower in infants born SGA, and will be positively correlated with total daily zinc intake.
4. The size of the EZP at birth will be significantly smaller in absolute size and relative to body weight in infants born SGA compared to AGA

Conditions

  • Micronutrients
  • Gestational Age

Sponsors & Collaborators

  • International Atomic Energy Agency

    collaborator OTHER_GOV

  • University of Colorado, Denver

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Completion
2009-07-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01140256 on ClinicalTrials.gov