RECRUITING

Iron Supplementation and Intestinal Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation. The primary outcomes are intestinal health including microbiome, inflammation, and barrier function.

Official Title

Enteral Iron Supplementation and Intestinal Health in Preterm Infants

Quick Facts

Study Start:2020-11-17
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04497012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * \<1500 g at birth, expected to live beyond 2 weeks, not yet started on oral iron supplementation (OIS), with mother at least 18 years of age, and parental consent.
  1. * congenital intestinal defects, history of intestinal infection or perforation before OIS. Infants who require epogen for religious reason to prevent them from getting blood transfusions will be excluded from the study.

Contacts and Locations

Study Contact

Marcia Kneusel
CONTACT
813-844-3395
mkneusel@usf.edu

Study Locations (Sites)

Tampa General Hospital
Tampa, Florida, 33606
United States

Collaborators and Investigators

Sponsor: University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-17
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2020-11-17
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • intestinal dysbiosis

Additional Relevant MeSH Terms

  • Anemia of Prematurity
  • Very Low Birth Weight Infant