Preterm InfantsNCT02066610
Effect of Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Infants
A study testing selenium and sodium selenate supplementation, selenium and sodium selenite supplementation and Without selenium and sodium selenate supplementation in people with Preterm Infants, run by Abbott Nutrition at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Infants
- What is being tested?
- selenium and sodium selenate supplementation, selenium and sodium selenite supplementation and Without selenium and sodium selenate supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1991to Jun 1993
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weight less than 1500 g at birth
- Not capable of receiving enteral feedings prior to 7 days postnatally
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
About this study
Official title: Effect of Parenteral and Enteral Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Low Birth Weight Infants
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.
- Conditions
- Preterm Infants
- Being tested
- selenium and sodium selenate supplementation, selenium and sodium selenite supplementation, Without selenium and sodium selenate supplementation, Without selenium and sodium selenite supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Without selenium and sodium selenite supplementationOther
Parenteral nutrition without selenium and sodium selenite supplementation of infant formula
| Study group | Role | What they receive |
|---|---|---|
| PN selenium and formula sodium selenate | Experimental | Parenteral nutrition (PN) with selenium and sodium selenate supplementation of infant formula Receives: 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 Receives: 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 Receives: 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 Receives: Other: Without selenium and sodium selenite supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline to Discharge (~50-60 days)
Secondary outcomes (10)
Weight
Weight at study day 1, at first enteral feed, at full enteral feeding, and at study exit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline to Discharge (~50-60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 1991
- Primary completionJun 1993
- Study completionJun 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Borschel, Ph.D, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066610
- Sponsor's protocol ID
- AD61
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Parenteral and Enteral Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT02066610
- Acronym / sponsor ID
- AD61
- Conditions
- Preterm Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 1991
- Primary completion
- Jun 1993 (actual)
- Study completion
- Jun 1993 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PN selenium and formula sodium selenate | Experimental | Other: selenium and sodium selenate supplementationParenteral nutrition (PN) with selenium and sodium selenate supplementation of infant formula |
| PN selenium and formula sodium selenite | Experimental | Other: selenium and sodium selenite supplementationParenteral nutrition (PN) with selenium and sodium selenite supplementation of infant formula |
| PN without selenium and formula sodium selenate | Experimental | Other: Without selenium and sodium selenate supplementationParenteral nutrition (PN) without selenium and sodium selenate supplementation of infant formula |
| PN without selenium and formula sodium selenite | Experimental | Other: Without selenium and sodium selenite supplementationParenteral nutrition (PN) without selenium and sodium selenite supplementation of infant formula |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Weight less than 1500 g at birth
- Not capable of receiving enteral feedings prior to 7 days postnatally
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selenium and sodium selenate supplementationParenteral nutrition with selenium and sodium selenate supplementation of infant formula | Other | PN selenium and formula sodium selenate |
| selenium and sodium selenite supplementationParenteral nutrition with selenium and sodium selenite supplementation of infant formula | Other | PN selenium and formula sodium selenite |
| Without selenium and sodium selenate supplementationParenteral nutrition without selenium and sodium selenate supplementation of infant formula | Other | PN without selenium and formula sodium selenate |
| Without selenium and sodium selenite supplementationParenteral nutrition without selenium and sodium selenite supplementation of infant formula | Other | PN without selenium and formula sodium selenite |
Primary outcome
Serum Selenium
Time frame: Change from Baseline to Discharge (~50-60 days)
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
10 secondary outcomes
Weight
Time frame: Change from study day 1 to study exit (~50-60 days)
Length
Time frame: Change from study day 1 to study exit (~50-60 days)
Head Circumference
Time frame: Change from study day 1 to study exit (~50-60 days)
Intake
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
Time frame: Change from Baseline to Discharge (~50-60 days)
WBC Super oxide dismutase (SOD) activity
Time frame: Change from Baseline to Discharge (~50-60 days)
Glutathione peroxidase (GSHpx) activity
Time frame: Change from Baseline to Discharge (~50-60 days)
Plasma GSHpx activity
Time frame: Change from Baseline to Discharge (~50-60 days)
Plasma Amino Acid Concentrations
Time frame: Change from Baseline to Discharge (~50-60 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Borschel, Ph.D study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selenium and sodium selenate supplementation, selenium and sodium selenite supplementation and Without selenium and sodium selenate supplementation in people with Preterm Infants, run by Abbott Nutrition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Selenium (time frame: Change from Baseline to Discharge (~50-60 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.