NCT02066610

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 1991

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1991

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1993

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1993

Completed
20.7 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

February 4, 2014

Last Update Submit

February 18, 2014

Conditions

Preterm Infants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Weight

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

  • Length

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

  • Head Circumference

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

  • Intake

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

  • Serum Copper

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

  • +5 more secondary outcomes

Study Arms (4)

PN selenium and formula sodium selenate

EXPERIMENTAL

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

Other: selenium and sodium selenate supplementation

PN selenium and formula sodium selenite

EXPERIMENTAL

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

Other: selenium and sodium selenite supplementation

PN without selenium and formula sodium selenate

EXPERIMENTAL

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

Other: Without selenium and sodium selenate supplementation

PN without selenium and formula sodium selenite

EXPERIMENTAL

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

Other: Without selenium and sodium selenite supplementation

Interventions

selenium and sodium selenate supplementationOTHER

Parenteral nutrition with selenium and sodium selenate supplementation of infant formula

PN selenium and formula sodium selenate
selenium and sodium selenite supplementationOTHER

Parenteral nutrition with selenium and sodium selenite supplementation of infant formula

PN selenium and formula sodium selenite
Without selenium and sodium selenate supplementationOTHER

Parenteral nutrition without selenium and sodium selenate supplementation of infant formula

PN without selenium and formula sodium selenate
Without selenium and sodium selenite supplementationOTHER

Parenteral nutrition without selenium and sodium selenite supplementation of infant formula

PN without selenium and formula sodium selenite

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Weight less than 1500 g at birth
  • Not capable of receiving enteral feedings prior to 7 days postnatally

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

MeSH Terms

Interventions

Selenium

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Marlene Borschel, Ph.D

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 19, 2014

Study Start

March 1, 1991

Primary Completion

June 1, 1993

Study Completion

June 1, 1993

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

US(1)