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

N/ACompletedNCT02066610

Abbott Nutrition47 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Preterm Infants

Interventions

selenium and sodium selenate supplementationOTHER

Parenteral nutrition with selenium and sodium selenate supplementation of infant formula

selenium and sodium selenite supplementationOTHER

Parenteral nutrition with selenium and sodium selenite supplementation of infant formula

Without selenium and sodium selenate supplementationOTHER

Parenteral nutrition without selenium and sodium selenate supplementation of infant formula

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Legacy Emanuel Children's Hospital

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Time frame: Change from Baseline to Discharge (~50-60 days)

Secondary Outcomes

Weight

Weight at study day 1, at first enteral feed, at full enteral feeding, and at study exit

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Change from study day 1 to study exit (~50-60 days)

Serum Copper

Time frame: Change from Baseline to Discharge (~50-60 days)

Serum Zinc

Data from ClinicalTrials.gov

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