Critical CareNCT03166956
Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients
A study testing Glutamine and vitamin C enteral supplement in people with Critical Care, run by Chung Shan Medical University.
Trial summary
Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and vitamin C potentially have beneficial effects on wound healing and a reduction in infection rate. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Critical Care
- What is being tested?
- Glutamine and vitamin C enteral supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2012to 31 Dec 2014
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages 20 and 85 years
- Not enrolled in other clinical trials in the previous 1 month and during the study period
- Surgical ICU patients cared by the 9 participating surgeons
Who cannot join
- Older than age 85 years
- Pregnant women
- With an abnormal liver function (receiving drugs or clinical therapies)
- Abnormal renal function (under hemodialysis)
- Multiple organ failure (more than 2 organs)
- Expected ICU stay of less than 72 hours
About this study
Official title: The Effect of Enteral Glutamine and Vitamin C Supplementation on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients: A Prospective, Double-Blind, Randomized Controlled Trial
Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and vitamin C potentially have beneficial effects on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.
Read the detailed description
Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementation of glutamine in ICU patients has been under much debate. Another nutritional supplement, vitamin C, had a beneficial effect on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.
Methods. This is a prospective double-blind randomized study for surgical ICU patients whom can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA group); the control (C) group was provided with maltodextrin of equivalent calories as that provided in the GA group. Plasma glutamine, interleukin-6 (IL-6), and clinical data were collected and analyzed with biostatistical methods.
- Conditions
- Critical Care
- Being tested
- Glutamine and vitamin C enteral supplement
- Keywords
- Vitamin C, Glutamine, Interleukin-6, Clinical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutamine and vitamin C enteral supplementDietary supplement
Subjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan). Subjects in the C group received isocaloric maltodextrin as placebo.
| Study group | Role | What they receive |
|---|---|---|
| GA (glutamine and vitamin C) group | Experimental | Interventions of glutamine and vitamin C enteral supplementations were given to surgical intensive care unit (ICU) patients.
Subjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan). Receives: Dietary Supplement: Glutamine and vitamin C enteral supplement |
| Control (C) group | Placebo comparator | Placebo:
Subjects in the C group received isocaloric maltodextrin as placebo. Receives: Dietary Supplement: Glutamine and vitamin C enteral supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6
Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.
Measured: Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.
Interleukin-10
Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.
Measured: Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.
Body mass index (BMI)
body height and weight were taken and body mass index (BMI) calculated at baseline.
Measured: At enrollment.
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
APACHE II score was calculated to classify the disease severity.
Measured: At enrollment.
Plasma glutamine
Blood was collected for analyses of plasma glutamine levels
Measured: Blood samples were collected for biochemical analyses on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Red blood cells
Blood was collected for hematological analyses
Measured: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Hemoglobin
Blood was collected for hematological analyses
Measured: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
White blood cells
Hematological analyses
Measured: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
C reactive protein
Hematological analyses
Measured: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Secondary outcomes (6)
Length of hospital stay
Clinical outcome
Measured: Up to one year
Length of ICU stay
Clinical outcome
Measured: Up to one year
Duration of ventilator use
Clinical outcome
Measured: Up to one year
ICU infectious complications
Clinical outcome
Measured: Up to one year
Mortality in ICU stay
Clinical outcome
Measured: Up to one year
Mortality in hospital stay
Clinical outcome
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Jun 2012
- Primary completion31 Aug 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Lin, MD, PhD, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166956
- Sponsor's protocol ID
- CS#12181
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enteral Glutamine and Vitamin C Supplementation on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients: A Prospective, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03166956
- Acronym / sponsor ID
- CS#12181
- Conditions
- Critical Care
- Keywords
- Vitamin C, Glutamine, Interleukin-6, Clinical outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 25 May 2017 (actual)
- 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.
Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and vitamin C potentially have beneficial effects on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.
Detailed description
Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementation of glutamine in ICU patients has been under much debate. Another nutritional supplement, vitamin C, had a beneficial effect on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.
Methods. This is a prospective double-blind randomized study for surgical ICU patients whom can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA group); the control (C) group was provided with maltodextrin of equivalent calories as that provided in the GA group. Plasma glutamine, interleukin-6 (IL-6), and clinical data were collected and analyzed with biostatistical methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| GA (glutamine and vitamin C) group | Experimental | Dietary Supplement: Glutamine and vitamin C enteral supplementInterventions of glutamine and vitamin C enteral supplementations were given to surgical intensive care unit (ICU) patients. Subjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan). |
| Control (C) group | Placebo comparator | Dietary Supplement: Glutamine and vitamin C enteral supplementPlacebo: Subjects in the C group received isocaloric maltodextrin as placebo. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages 20 and 85 years
- Not enrolled in other clinical trials in the previous 1 month and during the study period
- Surgical ICU patients cared by the 9 participating surgeons
Key exclusion criteria (6 listed)
- Older than age 85 years
- Pregnant women
- With an abnormal liver function (receiving drugs or clinical therapies)
- Abnormal renal function (under hemodialysis)
- Multiple organ failure (more than 2 organs)
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 |
|---|---|---|
| Glutamine and vitamin C enteral supplementSubjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan). Subjects in the C group received isocaloric maltodextrin as placebo. | Dietary supplement | Control (C) group, GA (glutamine and vitamin C) group |
Primary outcome
Interleukin-6
Time frame: Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.
Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.
Interleukin-10
Time frame: Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.
Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.
Body mass index (BMI)
Time frame: At enrollment.
body height and weight were taken and body mass index (BMI) calculated at baseline.
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Time frame: At enrollment.
APACHE II score was calculated to classify the disease severity.
Plasma glutamine
Time frame: Blood samples were collected for biochemical analyses on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Blood was collected for analyses of plasma glutamine levels
Red blood cells
Time frame: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Blood was collected for hematological analyses
Hemoglobin
Time frame: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Blood was collected for hematological analyses
White blood cells
Time frame: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Hematological analyses
C reactive protein
Time frame: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Hematological analyses
6 secondary outcomes
Length of hospital stay
Time frame: Up to one year
Length of ICU stay
Time frame: Up to one year
Duration of ventilator use
Time frame: Up to one year
ICU infectious complications
Time frame: Up to one year
Mortality in ICU stay
Time frame: Up to one year
Mortality in hospital stay
Time frame: Up to one year
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 30 May 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamine and vitamin C enteral supplement in people with Critical Care, run by Chung Shan Medical University.
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 3 inclusion and 6 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Interleukin-6 (time frame: Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.). The study lists 9 primary outcomes in all. 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 30 May 2017.