30 Participants NeededMy employer runs this trial

Zinc Supplementation for Prematurity/Low Birthweight

JN
Overseen ByJulia Newman, DO
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: Augusta University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Preterm infants born prematurely are more likely to have low zinc levels because they have less time to build up zinc before birth. They also have smaller zinc stores after birth and may need more zinc to support their rapid growth.

This study will examine how growth is affected in premature babies receiving either the current dose or a higher dose of zinc supplementation. The zinc supplement will be given daily, starting according to the unit's standard feeding guidelines, and will be stopped based on usual standard-of-care practices.

Possible risks of zinc supplementation include gastrointestinal intolerance (such as vomiting, diarrhea, or stomach discomfort) and anemia.

Possible benefits include improved growth, a stronger immune system, a shorter hospital stay, and lower healthcare costs.

Who Is on the Research Team?

LW

Lauren Walker, DO

Principal Investigator

Augusta University

Are You a Good Fit for This Trial?

This trial is for premature babies with low birthweight or bronchopulmonary dysplasia who may need extra zinc to support growth. Babies are included if they are preterm and meet the hospital's feeding guidelines.

Inclusion Criteria

Birth weight between 750 and 1500 grams

Exclusion Criteria

I have had a spontaneous hole in my intestine.
I have been diagnosed with necrotizing enterocolitis.
I have a history of major gastrointestinal birth defects.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Zinc Supplementation

Trial Overview

The study compares two daily doses of zinc supplements (1 mg vs. 3 mg) in premature infants to see which dose better supports healthy weight gain and growth. Babies are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Lower Zinc SupplementationExperimental Treatment1 Intervention
Group II: Higher Zinc SupplementationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials
219
Recruited
85,900+