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

Not Applicable

Completed

• Conditions: Preterm Infants

• Registration Number: NCT02066610
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1991-03
• Primary Completion: 1993-06
• Study Completion: 1993-06
• Status Verified: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-18
• Last Update Submitted: 2014-02-18
• Study First Posted: 2014-02-19
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum Selenium	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 Outcome Measures

Name	Time	Method
Intake	Change from study day 1 to study exit (~50-60 days)	Daily recording of volume and calories from parenteral solutions and study formula consumed
Serum Copper	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
Serum Zinc	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
WBC Super oxide dismutase (SOD) activity	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
Glutathione peroxidase (GSHpx) activity	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
Plasma GSHpx activity	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
Plasma Amino Acid Concentrations	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
Weight	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
Length	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
Head Circumference	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

Trial Locations

Locations (1)

Legacy Emanuel Children's Hospital; 🇺🇸 Portland, Oregon, United States