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

Overview

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.

Full Title of Study: “Effect of Parenteral and Enteral Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Low Birth Weight Infants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 1993

Interventions

  • Other: selenium and sodium selenate supplementation
    • Parenteral nutrition with selenium and sodium selenate supplementation of infant formula
  • Other: selenium and sodium selenite supplementation
    • Parenteral nutrition with selenium and sodium selenite supplementation of infant formula
  • Other: Without selenium and sodium selenate supplementation
    • Parenteral nutrition without selenium and sodium selenate supplementation of infant formula
  • Other: Without selenium and sodium selenite supplementation
    • Parenteral nutrition without selenium and sodium selenite supplementation of infant formula

Arms, Groups and Cohorts

  • Experimental: PN selenium and formula sodium selenate
    • Parenteral nutrition (PN) 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
  • Experimental: PN without selenium and formula sodium selenate
    • Parenteral nutrition (PN) 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Nutrition
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marlene Borschel, Ph.D, Study Chair, Abbott Nutrition

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