Iron Supplementation and Intestinal Health

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.

Conditions

Anemia of Prematurity, Very Low Birth Weight Infant

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Study Overview

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Study Details

Study overview

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.

Enteral Iron Supplementation and Intestinal Health in Preterm Infants

Iron Supplementation and Intestinal Health

Condition
Anemia of Prematurity
Intervention / Treatment

-

Contacts and Locations

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * \<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.
  • * 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.

Ages Eligible for Study

1 Day to 6 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of South Florida,

Study Record Dates

2025-07-31