Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2019-08-29
2021-03-30
Brief Summary
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Detailed Description
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Aim #2: To study the association between Zn levels in red blood cells and nutritional status in PWCF at 3 months to 3 years of age and compare it to the association between serum Zn and nutritional status in the same population. Hypothesis: Lower Zn levels in red blood cells is associated with poorer nutritional status in infant and young PWCF and is a better measure of Zn status compared to serum Zn.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Pediatric CF Patients
Pediatric patients ages 3 months to 3 years with CF identified via newborn screening.
Serum Zn
The investigators will obtain an additional 2 mL of blood in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.
Red Blood Cell Zn
If the participant is greater or equal than 5 kg, an additional 2 mL of blood will be obtained in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.
Interventions
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Serum Zn
The investigators will obtain an additional 2 mL of blood in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.
Red Blood Cell Zn
If the participant is greater or equal than 5 kg, an additional 2 mL of blood will be obtained in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of prematurity (born prior to completing 36 weeks 6 days gestation)
3 Months
3 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Sarah Bauer
Assistant Professor, School of Medicine
Principal Investigators
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Clement Ren, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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1907847033
Identifier Type: -
Identifier Source: org_study_id
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