Zinc Status and Growth in Cystic Fibrosis

NCT ID: NCT04302428

Last Updated: 2023-03-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-29

Study Completion Date

2021-03-30

Brief Summary

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The purpose of this study is to improve the understanding of the relationship of zinc status and growth in infants and young children who were diagnosed with cystic fibrosis via newborn screening.

Detailed Description

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The objective of this study is to improve the understanding of the relationship of zinc (Zn) status and growth in infant and young people with cystic fibrosis (PWCF). The investigators hypothesize that Zn deficiency in infant and young PWCF is associated with poor growth.

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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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients ages 3 months to 3 years with CF identified via new born screening

Exclusion Criteria

* History of meconium ileus
* History of prematurity (born prior to completing 36 weeks 6 days gestation)
Minimum Eligible Age

3 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Sarah Bauer

Assistant Professor, School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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1907847033

Identifier Type: -

Identifier Source: org_study_id

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