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

Abbott Nutrition1 site in 1 country47 target enrollmentMarch 1991

ConditionsPreterm Infants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Preterm Infants
Sponsor: Abbott Nutrition
Enrollment: 47
Locations: 1
Primary Endpoint: Serum Selenium
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 1991

End Date

June 1993

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Intake(Change from study day 1 to study exit (~50-60 days))
Serum Copper(Change from Baseline to Discharge (~50-60 days))
Serum Zinc(Change from Baseline to Discharge (~50-60 days))
WBC Super oxide dismutase (SOD) activity(Change from Baseline to Discharge (~50-60 days))
Glutathione peroxidase (GSHpx) activity(Change from Baseline to Discharge (~50-60 days))
Plasma GSHpx activity(Change from Baseline to Discharge (~50-60 days))
Plasma Amino Acid Concentrations(Change from Baseline to Discharge (~50-60 days))
Weight(Change from study day 1 to study exit (~50-60 days))
Length(Change from study day 1 to study exit (~50-60 days))
Head Circumference(Change from study day 1 to study exit (~50-60 days))