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Trial record 8 of 167 for:    selenium

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT02066610
First received: February 4, 2014
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Preterm Infants
Other: selenium and sodium selenate supplementation
Other: selenium and sodium selenite supplementation
Other: Without selenium and sodium selenate supplementation
Other: Without selenium and sodium selenite supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effect of Parenteral and Enteral Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Serum Selenium [ Time Frame: Change from Baseline to Discharge (~50-60 days) ] [ Designated as safety issue: No ]
    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:
  • Weight [ Time Frame: Change from study day 1 to study exit (~50-60 days) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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


Enrollment: 47
Study Start Date: March 1991
Study Completion Date: June 1993
Primary Completion Date: June 1993 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066610

Locations
United States, Oregon
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Marlene Borschel, Ph.D Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02066610     History of Changes
Other Study ID Numbers: AD61
Study First Received: February 4, 2014
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Selenium
Antioxidants
Micronutrients
Selenic Acid
Selenious Acid
Sodium Selenite
Trace Elements
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 25, 2014