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

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066610
• Other study ID #: AD61
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: February 18, 2014
• Start date: March 1991
• Est. completion date: June 1993

Study information

• Verified date: February 2014
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 1993
• Est. primary completion date: June 1993
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Preterm Infants

Intervention

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

Locations

Country	Name	City	State
United States	Legacy Emanuel Children's Hospital	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Selenium	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	Change from Baseline to Discharge (~50-60 days)	No
Secondary	Weight	Weight at study day 1, at first enteral feed, at full enteral feeding, and at study exit	Change from study day 1 to study exit (~50-60 days)	No
Secondary	Length	Length at study day 1, at first enteral feed, at full enteral feeding, and at study exit	Change from study day 1 to study exit (~50-60 days)	No
Secondary	Head Circumference	Head circumference at study day 1, at first enteral feed, at full enteral feeding, and at study exit	Change from study day 1 to study exit (~50-60 days)	No
Secondary	Intake	Daily recording of volume and calories from parenteral solutions and study formula consumed	Change from study day 1 to study exit (~50-60 days)	No
Secondary	Serum Copper	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	Change from Baseline to Discharge (~50-60 days)	No
Secondary	Serum Zinc	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	Change from Baseline to Discharge (~50-60 days)	No
Secondary	WBC Super oxide dismutase (SOD) activity	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	Change from Baseline to Discharge (~50-60 days)	No
Secondary	Glutathione peroxidase (GSHpx) activity	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	Change from Baseline to Discharge (~50-60 days)	No
Secondary	Plasma GSHpx activity	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	Change from Baseline to Discharge (~50-60 days)	No
Secondary	Plasma Amino Acid Concentrations	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	Change from Baseline to Discharge (~50-60 days)	No