Skip to main content
OpenTrials
Completed

NCT Number: NCT04302428

Zinc Status and Growth in Cystic Fibrosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 month–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Serum Zn

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

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.

Primary outcomes

  1. Zinc Status

    Time frame: 1 day

    Zn status in infant and young PWCF as measured by serum Zn and red blood cell Zn

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2020
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.