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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-03-31

Study Completion Date

1993-06-30

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.

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Detailed Description

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Conditions

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Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PN selenium and formula sodium selenate

Parenteral nutrition (PN) with selenium and sodium selenate supplementation of infant formula

Group Type EXPERIMENTAL

selenium and sodium selenate supplementation

Intervention Type OTHER

Parenteral nutrition with selenium and sodium selenate supplementation of infant formula

PN selenium and formula sodium selenite

Parenteral nutrition (PN) with selenium and sodium selenite supplementation of infant formula

Group Type EXPERIMENTAL

selenium and sodium selenite supplementation

Intervention Type OTHER

Parenteral nutrition with selenium and sodium selenite supplementation of infant formula

PN without selenium and formula sodium selenate

Parenteral nutrition (PN) without selenium and sodium selenate supplementation of infant formula

Group Type EXPERIMENTAL

Without selenium and sodium selenate supplementation

Intervention Type OTHER

Parenteral nutrition without selenium and sodium selenate supplementation of infant formula

PN without selenium and formula sodium selenite

Parenteral nutrition (PN) without selenium and sodium selenite supplementation of infant formula

Group Type EXPERIMENTAL

Without selenium and sodium selenite supplementation

Intervention Type OTHER

Parenteral nutrition without selenium and sodium selenite supplementation of infant formula

Interventions

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selenium and sodium selenate supplementation

Parenteral nutrition with selenium and sodium selenate supplementation of infant formula

Intervention Type OTHER

selenium and sodium selenite supplementation

Parenteral nutrition with selenium and sodium selenite supplementation of infant formula

Intervention Type OTHER

Without selenium and sodium selenate supplementation

Parenteral nutrition without selenium and sodium selenate supplementation of infant formula

Intervention Type OTHER

Without selenium and sodium selenite supplementation

Parenteral nutrition without selenium and sodium selenite supplementation of infant formula

Intervention Type OTHER

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No