MicronutrientsEZPNCT01140256
Longitudinal Zinc Intakes and Exchangeable Zinc Pool Sizes in Breastfed Small for Gestational Age vs Appropriate for Gestational Age Infants in Pakistan
An observational study of Micronutrients and Gestational Age, run by Aga Khan University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Micronutrients, Gestational Age
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2007to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: SGA and AGA infants born to healthy mothers.
Who may be able to join
- Mothers: Healthy women 18-40 yr; primips or multips; Infants: Healthy at birth
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- 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.
- Compare post-natal growth rates for SGA and AGA infants through the first 12 mo of life in relation to zinc intake.
- Compare size of exchangeable zinc pool (EZP) at birth and at 6 mo of age between SGA and AGA infants.
Read more
Hypotheses:
- 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.
- 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.
- 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.
- 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
Read the detailed description
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:
- 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.
- Compare post-natal growth rates for SGA and AGA infants through the first 12 mo of life in relation to zinc intake.
- 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.
- Conditions
- Micronutrients, Gestational Age
- Keywords
- Zinc, SGA, AGA, stable isotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJan 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicronutrientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140256
- Sponsor's protocol ID
- 585-Ped/ERC-06
- Acronym
- EZP
- Status last verified
- Jul 2009
- First submitted
- 8 Jun 2010
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Zinc Intakes and Exchangeable Zinc Pool Sizes in Breastfed Small for Gestational Age vs Appropriate for Gestational Age Infants in Pakistan
- ClinicalTrials.gov ID
- NCT01140256
- Acronym / sponsor ID
- EZP / 585-Ped/ERC-06
- Conditions
- Micronutrients, Gestational Age
- Keywords
- Zinc, SGA, AGA, stable isotope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency, University of Colorado, Denver
- Study start
- Jan 2007
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Compare post-natal growth rates for SGA and AGA infants through the first 12 mo of life in relation to zinc intake.
- Compare size of exchangeable zinc pool (EZP) at birth and at 6 mo of age between SGA and AGA infants.
Hypotheses:
- 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.
- 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.
- 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.
- 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
Detailed description
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:
- 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.
- Compare post-natal growth rates for SGA and AGA infants through the first 12 mo of life in relation to zinc intake.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- SGA and AGA infants born to healthy mothers.
Key inclusion criteria (1 listed)
- Mothers: Healthy women 18-40 yr; primips or multips; Infants: Healthy at birth
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Micronutrients and Gestational Age, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Compare size of exchangeable zinc pool (EZP) at birth and at 6 mo of age between SGA and AGA infants. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.