MedTrace Logo

Iron Supplementation and Intestinal Health

NCT04497012 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2025-01-22

No results posted yet for this study

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

Interventions

DRUG

2mg/kg/day Iron Sulfate

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

DRUG

6 mg/kg/day Iron Sulfate

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2025-03-30
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04497012 on ClinicalTrials.gov