Micronutrients Clinical Trial
— EZPOfficial title:
Longitudinal Zinc Intakes and Exchangeable Zinc Pool Sizes in Breastfed Small for Gestational Age vs Appropriate for Gestational Age Infants in Pakistan
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
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2009 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 48 Hours |
Eligibility |
Inclusion Criteria: Mothers: Healthy women 18-40 yr; primips or multips; Infants: Healthy at birth Exclusion Criteria: Mothers: tobacco or alcohol use during pregnancy; HIV or chronic infection such as TB. Infants: twins/multiples; congenital infections, malformations; gestational age < 37 wk ; severe anemia at birth. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan university | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University | International Atomic Energy Agency, University of Colorado, Denver |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To Compare size of exchangeable zinc pool (EZP) at birth and at 6 mo of age between SGA and AGA infants | We measured the exchangeable zinc pool sizes in exclusively breast fed infants at birth and then at 6 months of age among the SGA and AGA infants by zinc stable isotope technique.Intravenous dose of pre measured was administered.Urine was collected and analyzed for enrichemnt of zinc isotope.The entire procedure was repeated at 6 months. | Yes |
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