Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

February 3, 2023 updated by: Suzan Sahin, Zekai Tahir Burak Women's Health Research and Education Hospital
  • Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.
  • Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life.
  • Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.
  • There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants.
  • Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally believed to be in a negative Zn balance in the early period of life. In this study, we aimed to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW) infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (NEC), late-onset sepsis (LOS).

Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of <32 weeks were randomly allocated on the seventh day of life to receive extra amount of supplemental zinc along with the enteral feedings or not, besides regular low dose supplementation, from enrollment until discharge. Outcome measures were feeding intolerance, NEC (stage≥2), LOS and mortality.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 35290
        • Izmir Democracy University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • < 32 weeks gestational age and/or <1500 gr birth weight
  • Born in the study hospital
  • Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient

Exclusion Criteria:

  • Major congenital malformations and/or critical congenital heart defects
  • Born in another hospital
  • Severe birth asphyxia
  • Severe sepsis
  • Previous early-onset NEC history
  • Infants on the intervention arm who did not continue Zinc supplementation during the study period
  • Hemodynamically unstability
  • Infants nil per os
  • No consent from the family
  • Death before the 7th day of life

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zinc intervention
9 mg/day Zinc suspension via og tube along with the routinely used standard multivitamin product containing 3 mg daily dose of Zn, started on day 7 until discharge from hospital
Drug: Zinc Sulfate
NO_INTERVENTION: Control
These infants received only standard commercial multivitamin product containing 3 mg daily dose of Zn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of feeding intolerance
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of hospitalization
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Number of participants with necrotising enterocolitis (stage≥2)
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Incidence of mortality
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Number of participants with late onset sepsis
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Number of participants with retinopathy of prematurity
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months
Number of participants with bronchopulmonary dysplasia
Time Frame: through study completion, an average of 6 months
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Collaborators

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 14, 2014

Primary Completion (ACTUAL)

March 2, 2015

Study Completion (ACTUAL)

April 20, 2015

Study Registration Dates

First Submitted

May 19, 2019

First Submitted That Met QC Criteria

March 25, 2022

First Posted (ACTUAL)

April 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZincVLBW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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