Zinc Status and Growth in Cystic Fibrosis | NCT04302428

Studies
Zinc Status and Growth in Cystic Fibrosis

NCT04302428

Sponsor

Indiana University

Status

Completed

Last Update Posted

Mar 20, 2023Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Cystic
Fibrosis

Interventions

Serum Zn
Red Blood Cell Zn

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2019Actual

Primary Completion Date

Mar 30, 2021Actual

Completion Date

Mar 30, 2021Actual

First Submitted Date

Mar 6, 2020

First Submission Date that Met QC Criteria

Mar 6, 2020

First Posted Date

Mar 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric CF Patients		Pediatric patients ages 3 months to 3 years with CF identified via newborn screening.	Biological: Serum Zn Biological: Red Blood Cell Zn

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

3 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clement Ren, MD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Riley Hospital for Children at Indiana University Health		Indianapolis	Indiana	46202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided