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

Study Overview
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Brief Summary
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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.

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

Conditions
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Preterm Infants

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PN selenium and formula sodium selenate<br>Parenteral nutrition (PN) with selenium and sodium selenate supplementation of infant formula | Other: selenium and sodium selenate supplementation<br>* Parenteral nutrition with selenium and sodium selenate supplementation of infant formula<br>|
| Experimental: PN selenium and formula sodium selenite<br>Parenteral nutrition (PN) with selenium and sodium selenite supplementation of infant formula | Other: selenium and sodium selenite supplementation<br>* Parenteral nutrition with selenium and sodium selenite supplementation of infant formula<br>|
| Experimental: PN without selenium and formula sodium selenate<br>Parenteral nutrition (PN) without selenium and sodium selenate supplementation of infant formula | Other: Without selenium and sodium selenate supplementation<br>* Parenteral nutrition without selenium and sodium selenate supplementation of infant formula<br>|
| Experimental: PN without selenium and formula sodium selenite<br>Parenteral nutrition (PN) without selenium and sodium selenite supplementation of infant formula | Other: Without selenium and sodium selenite supplementation<br>* Parenteral nutrition without selenium and sodium selenite supplementation of infant formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |