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Search / Trial NCT04497012

Iron Supplementation and Intestinal Health

Launched by UNIVERSITY OF SOUTH FLORIDA · Jul 31, 2020

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Intestinal Dysbiosis

ClinConnect Summary

This clinical trial is studying the effects of iron supplementation on the intestinal health of very low birth weight infants, specifically those with anemia of prematurity. Researchers want to find out how different doses of iron—either a low dose of 2 mg/kg per day or a high dose of 6 mg/kg per day—affect important aspects of intestinal health, such as the balance of good bacteria, inflammation levels, and the strength of the intestinal barrier.

To participate in this trial, infants must weigh less than 1500 grams at birth and be expected to live beyond two weeks. They should not have started taking oral iron supplements yet, and their mothers need to be at least 18 years old and provide consent. Unfortunately, infants with certain intestinal problems or infections, or those needing specific blood treatment for religious reasons, cannot take part. If eligible, participants will receive daily iron supplements for the duration of the study and help researchers learn more about how iron can support the health of these vulnerable infants.

Gender

ALL

Eligibility criteria

  • Inclusion 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.
  • Exclusion Criteria:
  • 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.

About University Of South Florida

The University of South Florida (USF) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong commitment to improving patient outcomes, USF leverages its diverse faculty expertise and state-of-the-art facilities to conduct rigorous and ethically sound research. The university fosters collaboration across disciplines, engaging in partnerships that enhance the translation of scientific discoveries into effective therapeutic interventions. USF's clinical trial programs are designed to address pressing health challenges and contribute to the body of knowledge in various medical fields, ultimately aiming to benefit communities and improve public health.

Locations

Tampa, Florida, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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