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Completed

NCT Number: NCT02066610

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

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Key information

Conditions

Preterm Infants

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

selenium and sodium selenate supplementation

Other

Parenteral nutrition with selenium and sodium selenate supplementation of infant formula

selenium and sodium selenite supplementation

Other

Parenteral nutrition with selenium and sodium selenite supplementation of infant formula

Without selenium and sodium selenate supplementation

Other

Parenteral nutrition without selenium and sodium selenate supplementation of infant formula

Without selenium and sodium selenite supplementation

Other

Parenteral nutrition without selenium and sodium selenite supplementation of infant formula

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

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

Important dates

Study start
1991
Primary completion
1993
Study completion
1993
First posted
Feb 19, 2014
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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