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

NCT01140256 | Completed

• 1 other identifier: 585-Ped/ERC-06
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Compare post-natal growth rates for SGA and AGA infants through the first 12 mo of life in relation to zinc intake.
3. 3.Compare size of exchangeable zinc pool (EZP) at birth and at 6 mo of age between SGA and AGA infants.
4. 4.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.
5. 5.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.
6. 6.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.
7. 7.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

Keywords

Zinc; SGA; AGA; stable isotope

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

SGA infants

SGA infants were recruited at birth and zinc stable isotope was administered at birth and at 6 months of age .This was a longitudinal study whereby the growth trajectory and zinc pools were measured.

AGA

AGA infants were recruited at birth and zinc stable isotope was administered at birth and at 6 months of age .This was a longitudinal study whereby the growth trajectory and zinc pools were measured.

SGA infant

Infants who were born small for gestational age were recruited and zinc stable isotopes were administered at birth and at 6 months.

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

SGA and AGA infants born to healthy mothers.

You may qualify if:

• Mothers: Healthy women 18-40 yr; primips or multips; Infants: Healthy at birth

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• International Atomic Energy Agency: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Aga Khan university

Karachi, Sindh, 74800, Pakistan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 9, 2010
• Study Start: January 1, 2007
• Study Completion: July 1, 2009
• Last Updated: June 9, 2010

Record last verified: 2009-07

Locations

PA (1)