Recruiting

Iron Supplementation

Sponsor:

University of South Florida

Code:

NCT04497012

Conditions

Anemia of Prematurity

Very Low Birth Weight Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

2mg/kg/day Iron Sulfate

6 mg/kg/day Iron Sulfate

Study Details

Brief summary:

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

Study ID

NCT04497012

Start date

Nov 17, 2020

Status verified date

Jan, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Mar 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

183 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Low Iron Sulfate Supplementation

Participants will be given 2 mg/kg/day total of elemental iron once a day when they are consuming 150-160 ml/kg/day of enteral feeds and are at least 14 days old. The total iron doses will be provided by fortification of feeds and liquid iron sulfate and will be weight adjusted once a week. The participants will receive the study iron dose until 36 week corrected gestational age or discharge, whichever comes first.

active comparator: High Iron Sulfate Supplementation

Participants will be given 6 mg/kg/day total of elemental iron once a day when they are consuming 150-160 ml/kg/day of enteral feeds and are at least 14 days old. The total iron doses will be provided by fortification of feeds and liquid iron sulfate and will be weight adjusted once a week. The participants will receive the study iron dose until 36 week corrected gestational age or discharge, whichever comes first.

Interventions

2mg/kg/day Iron Sulfate

Iron Sulfate will be given in liquid form via nasal or oral gastric tube with feeds.

6 mg/kg/day Iron Sulfate

Iron Sulfate will be given in liquid form via nasal or oral gastric tube with feeds.

Primary outcome measure

  • Change in stool bacterial percentages from before to after iron supplementation [ Time Frame: from baseline to 1 week and 2 weeks after iron supplementation started ]
  • Change in fecal calprotectin from before to after iron supplementation [ Time Frame: from baseline to 1 week and 2 weeks after iron supplementation started ]
  • Change in urine Claudin-3 and I-FABP from before to after iron supplementation [ Time Frame: from baseline to 1 week and 2 weeks after iron supplementation started ]

Central Contacts and Locations

Central contacts

Marcia Kneusel

813-844-3395mkneusel@usf.edu

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Marcia Kneusel

813-844-3395

More Information

Sponsor

University of South Florida

Last update posted

Jan 22, 2025

Last verified

Jan, 2024

Keywords

  • intestinal dysbiosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-01-22.