Effect of Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Infants

February 18, 2014 updated by: Abbott Nutrition

Effect of Parenteral and Enteral Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Low Birth Weight Infants

The objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium supplemented parenteral nutrition from initiation of parenteral nutrition until discontinuation of preterm formula or hospital discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

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

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Children's Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weight less than 1500 g at birth
  • Not capable of receiving enteral feedings prior to 7 days postnatally

Exclusion Criteria:

  • Metabolic abnormalities such as inborn errors of metabolism
  • Current viral infections
  • Enterocolitis confirmed by diagnosis
  • Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease
  • Evidence of chronic white blood cell disease

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PN selenium and formula sodium selenate
Parenteral nutrition (PN) with selenium and sodium selenate supplementation of infant formula
Other: selenium and sodium selenate supplementation
Parenteral nutrition with selenium and sodium selenate supplementation of infant formula
Experimental: PN selenium and formula sodium selenite
Parenteral nutrition (PN) with selenium and sodium selenite supplementation of infant formula
Other: selenium and sodium selenite supplementation
Parenteral nutrition with selenium and sodium selenite supplementation of infant formula
Experimental: PN without selenium and formula sodium selenate
Parenteral nutrition (PN) without selenium and sodium selenate supplementation of infant formula
Other: Without selenium and sodium selenate supplementation
Parenteral nutrition without selenium and sodium selenate supplementation of infant formula
Experimental: PN without selenium and formula sodium selenite
Parenteral nutrition (PN) without selenium and sodium selenite supplementation of infant formula
Other: Without selenium and sodium selenite supplementation
Parenteral nutrition without selenium and sodium selenite supplementation of infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Selenium
Time Frame: Change from Baseline to Discharge (~50-60 days)
4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge
Change from Baseline to Discharge (~50-60 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Change from study day 1 to study exit (~50-60 days)
Weight at study day 1, at first enteral feed, at full enteral feeding, and at study exit
Change from study day 1 to study exit (~50-60 days)
Length
Time Frame: Change from study day 1 to study exit (~50-60 days)
Length at study day 1, at first enteral feed, at full enteral feeding, and at study exit
Change from study day 1 to study exit (~50-60 days)
Head Circumference
Time Frame: Change from study day 1 to study exit (~50-60 days)
Head circumference at study day 1, at first enteral feed, at full enteral feeding, and at study exit
Change from study day 1 to study exit (~50-60 days)
Intake
Time Frame: Change from study day 1 to study exit (~50-60 days)
Daily recording of volume and calories from parenteral solutions and study formula consumed
Change from study day 1 to study exit (~50-60 days)
Serum Copper
Time Frame: Change from Baseline to Discharge (~50-60 days)
4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge
Change from Baseline to Discharge (~50-60 days)
Serum Zinc
Time Frame: Change from Baseline to Discharge (~50-60 days)
4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge
Change from Baseline to Discharge (~50-60 days)
WBC Super oxide dismutase (SOD) activity
Time Frame: Change from Baseline to Discharge (~50-60 days)
4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge
Change from Baseline to Discharge (~50-60 days)
Glutathione peroxidase (GSHpx) activity
Time Frame: Change from Baseline to Discharge (~50-60 days)
4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge
Change from Baseline to Discharge (~50-60 days)
Plasma GSHpx activity
Time Frame: Change from Baseline to Discharge (~50-60 days)
4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge
Change from Baseline to Discharge (~50-60 days)
Plasma Amino Acid Concentrations
Time Frame: Change from Baseline to Discharge (~50-60 days)
4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge
Change from Baseline to Discharge (~50-60 days)

Collaborators and Investigators

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

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Marlene Borschel, Ph.D, Abbott Nutrition

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

March 1, 1991

Primary Completion (Actual)

June 1, 1993

Study Completion (Actual)

June 1, 1993

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD61

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.

Clinical Trials on Preterm Infants

Clinical Trials on selenium and sodium selenate supplementation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe