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NCT04302428 Clinical Trial

Zinc Status and Growth in Cystic Fibrosis

Fibrosis Clinical Trial

Official title:
Zinc Status and Growth in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04302428
Other study ID # 1907847033
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 29, 2019
Est. completion date March 30, 2021

Study information
Verified date March 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date March 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Months to 3 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 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.

Locations
Country Name City State
United States Riley Hospital for Children at Indiana University Health Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Zinc Status Zn status in infant and young PWCF as measured by serum Zn and red blood cell Zn 1 day
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