UnknownPhase 4

Iron Supplementation and Intestinal Health

United States183 participantsStarted 2020-11-17

Plain-language 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.

Who can participate

Age range1 Day – 6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in stool bacterial percentages from before to after iron supplementation

Timeframe: from baseline to 1 week and 2 weeks after iron supplementation started

Change in fecal calprotectin from before to after iron supplementation

Timeframe: 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

Timeframe: from baseline to 1 week and 2 weeks after iron supplementation started

Trial details

NCT IDNCT04497012

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

Contact for this trial

Marcia Kneusel

813-844-3395 mkneusel@usf.edu

View on ClinicalTrials.gov More Anemia of Prematurity trials