Zinc Status and Growth in Cystic Fibrosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04302428

Enrollment

Registered

2020-03-10

Start date

2019-08-29

Completion date

2021-03-30

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic, Fibrosis

Keywords

Zinc, Growth, Nutrition, Cystic, Fibrosis

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.

Interventions

BIOLOGICALSerum 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.

BIOLOGICALRed 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.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

3 Months to 3 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026