NCT04302428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

March 6, 2020

Last Update Submit

March 17, 2023

Conditions

CysticFibrosis

Keywords

ZincGrowthNutritionCysticFibrosis

Outcome Measures

Primary Outcomes (1)

  • Zinc Status

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

    1 day

Study Arms (1)

Pediatric CF Patients

Pediatric patients ages 3 months to 3 years with CF identified via newborn screening.

Biological: Serum ZnBiological: Red Blood Cell Zn

Interventions

Serum ZnBIOLOGICAL

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.

Pediatric CF Patients
Red Blood Cell ZnBIOLOGICAL

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.

Pediatric CF Patients

Eligibility Criteria

Age3 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • History of meconium ileus
  • History of prematurity (born prior to completing 36 weeks 6 days gestation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clement Ren, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Medicine

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

August 29, 2019

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

March 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)