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Clinical trial

Enteral Iron Supplementation and Intestinal Health in Preterm Infants

ID
Name
Pro00041470
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.
Trial arms
Trial start
2020-11-17
Estimated PCD
2024-11-30
Trial end
2025-07-31
Status
Recruiting
Phase
Early phase I
Treatment
2mg/kg/day Iron Sulfate
Iron Sulfate will be given in liquid form via nasal or oral gastric tube with feeds.
Arms:
Low Iron Sulfate Supplementation
Other names:
Low dose iron supplementation
6 mg/kg/day Iron Sulfate
Iron Sulfate will be given in liquid form via nasal or oral gastric tube with feeds.
Arms:
High Iron Sulfate Supplementation
Other names:
High dose iron supplementation
Size
183
Primary endpoint
Change in stool bacterial percentages from before to after iron supplementation
from baseline to 1 week and 2 weeks after iron supplementation started
Change in fecal calprotectin from before to after iron supplementation
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
from baseline to 1 week and 2 weeks after iron supplementation started
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomize subjects to low and high dose iron supplementations', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The participants, care givers, medical teams, investigator, and outcome assessors are blinded from the iron treatment dose for the duration of the study. Only research pharmacists and members of the Data and Safety Monitor Board are unblinded during the study period.\n\nIn an event when the medical team urgently needs to know the iron dose the participant is receiving for proper clinical management of the subject, the principal investigator or a designee will be notified by cell phone. Their contact information are located in the medical workrooms and the unit pharmacy. The principal investigator or the designee will immediately call the research pharmacy phone to request an emergency unblinding of that particular participant. The principal investigator will inform IRB and the sponsor of the unblinding event within 24 hours.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 183, 'type': 'ESTIMATED'}}
Updated at
2023-06-08

1 organization

1 product

2 indications

Organization
University of South Florida
Product
Iron Sulfate
Indication
Anemia of Prematurity
Indication
Very Low Birth Weight Infant