NCT04302428

Zinc Status and Growth in Cystic Fibrosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 3 Months – 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic
• Fibrosis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-08-29
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2020-03-10
• Last updated: 2023-03-20

Locations

1 site across 1 country: United States