Zinc Status and Growth in Cystic Fibrosis

Completed

• Conditions: Cystic; Fibrosis
• Interventions: Biological: Serum Zn; Biological: Red Blood Cell Zn

• Registration Number: NCT04302428
• Lead Sponsor: Indiana University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-29
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

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Exclusion Criteria

• History of meconium ileus
• History of prematurity (born prior to completing 36 weeks 6 days gestation)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric CF Patients	Red Blood Cell Zn	Pediatric patients ages 3 months to 3 years with CF identified via newborn screening.
Pediatric CF Patients	Serum Zn	Pediatric patients ages 3 months to 3 years with CF identified via newborn screening.

Primary Outcome Measures

Name	Time	Method
Zinc Status	1 day	Zn status in infant and young PWCF as measured by serum Zn and red blood cell Zn

Trial Locations

Locations (1)

Riley Hospital for Children at Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States