Oxidative StressPhase 3NCT01888861
Effect of Alpha-lipoic Acid on Biochemical Markers and Important Outcomes in Patients Admitted to Intensive Care Units
A Phase 3 study testing alpha-lipoic acid in people with Oxidative Stress and Inflammation, run by najmeh hejazi at 1 site in Iran.
Trial summary
Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxidative Stress, Inflammation, Malnutrition
- What is being tested?
- alpha-lipoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Feb 2013to Sep 2013
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18;
- expected length of stay more than 7 days;
- using enteral feeding method during admitted to ICU
Who cannot join
- having the history of autoimmune disease
- severe renal or liver failure
- AIDS,
- hepatitis;
- having severe malnutrition at the admission time;
- having TPN at the admission time in ICU;
- extreme intolerance to enteral feeding.
Trial locations and contacts
1 site in 1 country.
Najmeh Hejazi, Ph.D contact
Iran1 site, 1 recruiting
- Recruiting
Shiraz University of Medical Sciences, Department of Nutrition
Shiraz, Fars, 7157617516
Najmeh Hejazi, PhD, n20hejazi@yahoo.com
Najmeh Hejazi, PhD
About this study
Official title: Evaluating the Effect of Alpha Lipoic Acid on Biochemical Markers, Length of Stay and Other Important Outcomes in Patients Admitted to Intensive Care Units.
Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. In this double blind clinical trial, the investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive care unit that the investigators expect to stay for more than 7 days in this ward and who have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After randomization of included patients by block randomization the investigators will give 900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency period, length of stay in ICU, mortality and decelerate of organ failures.
- Conditions
- Oxidative Stress, Inflammation, Malnutrition
- Being tested
- alpha-lipoic acid, placebo
- Keywords
- length of stay in ICU, ventilator free days
- Medical subject headings
- Inflammation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha-lipoic acidDietary supplement
the patients in this arm receive 900mg alpha-lipoic acid through NG tube.
placeboDrug
the patients in this arm were received 900mg placebo through NG tube.
| Study group | Role | What they receive |
|---|---|---|
| alpha-lipoic acid | Experimental | the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube. Receives: Dietary Supplement: alpha-lipoic acid |
| placebo | Placebo comparator | the patients in this arm were received 900mg placebo through NG tube. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay in ICU
number of days that patient stay in intensive care unit
Measured: day 28
mortality
percent of mortality
Measured: day 28
ventilator free days
show by days
Measured: 10 days
Secondary outcomes (11)
sequential organ failure assessment score
determine by SOFA score form
Measured: 10 days
insulin resistance
measure by HOMA calculation equation
Measured: 10 days
malondialdehyde
measure by spectrophotometery
Measured: 10 days
total antioxidant capacity
measure by eliza kit
Measured: 10 days
C reactive protein
measure by nephelometry method
Measured: 10 days
interleukin-6
measure by eliza kit
Measured: 10 days
Albumin
record from routine lab data of patients in hospital
Measured: 10 days
preAlbumin
by turbidimetric assay
Measured: 10 days
Total lymphocyte count
record from routine lab data of patients in hospital
Measured: 10 days
Mid arm circumference
measure by non flexible meter in mid arm
Measured: 10 days
total protein
record from routine lab data of patients in hospital
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- najmeh hejazi
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Responsible party
- Sponsor-investigator, najmeh hejazi, Shiraz University of Medical Sciences
- Investigators
- Najmeh Hejazi, Ph.D, Principal investigator, Shiraz University of Medical Sciences,Nutrition departmentZohreh Mazloom, PhD, Study director, Shiraz University of Medical Sciences, Faculty of NutritionFarid Zand, MD, Study chair, Shiraz University of Medical Sciences, anesthesiology and critical care research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888861
- Sponsor's protocol ID
- 916423
- Status last verified
- Jun 2013
- First submitted
- 23 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Alpha Lipoic Acid on Biochemical Markers, Length of Stay and Other Important Outcomes in Patients Admitted to Intensive Care Units.
- ClinicalTrials.gov ID
- NCT01888861
- Acronym / sponsor ID
- 916423
- Conditions
- Oxidative Stress, Inflammation, Malnutrition
- Keywords
- length of stay in ICU, ventilator free days
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- najmeh hejaziUniversity, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 28 Jun 2013 (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.
Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. In this double blind clinical trial, the investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive care unit that the investigators expect to stay for more than 7 days in this ward and who have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After randomization of included patients by block randomization the investigators will give 900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency period, length of stay in ICU, mortality and decelerate of organ failures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alpha-lipoic acid | Experimental | Dietary Supplement: alpha-lipoic acidthe patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube. |
| placebo | Placebo comparator | Drug: placebothe patients in this arm were received 900mg placebo through NG tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18;
- expected length of stay more than 7 days;
- using enteral feeding method during admitted to ICU
Key exclusion criteria (7 listed)
- having the history of autoimmune disease
- severe renal or liver failure
- AIDS,
- hepatitis;
- having severe malnutrition at the admission time;
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 |
|---|---|---|
| alpha-lipoic acidthe patients in this arm receive 900mg alpha-lipoic acid through NG tube. | Dietary supplement | alpha-lipoic acid |
| placebothe patients in this arm were received 900mg placebo through NG tube. | Drug | placebo |
Primary outcome
length of stay in ICU
Time frame: day 28
number of days that patient stay in intensive care unit
mortality
Time frame: day 28
percent of mortality
ventilator free days
Time frame: 10 days
show by days
11 secondary outcomes
sequential organ failure assessment score
Time frame: 10 days
insulin resistance
Time frame: 10 days
malondialdehyde
Time frame: 10 days
total antioxidant capacity
Time frame: 10 days
C reactive protein
Time frame: 10 days
interleukin-6
Time frame: 10 days
Albumin
Time frame: 10 days
preAlbumin
Time frame: 10 days
Total lymphocyte count
Time frame: 10 days
Mid arm circumference
Time frame: 10 days
total protein
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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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.
Najmeh Hejazi, Ph.D contact
Najmeh Hejazi, Ph.D principal investigator
Shiraz University of Medical Sciences,Nutrition department
Zohreh Mazloom, PhD study director
Shiraz University of Medical Sciences, Faculty of Nutrition
Farid Zand, MD study chair
Shiraz University of Medical Sciences, anesthesiology and critical care research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alpha-lipoic acid in people with Oxidative Stress and Inflammation, run by najmeh hejazi at 1 site in Iran.
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 7 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: status not confirmed, as of the sponsor's last update on 28 Jun 2013. 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 Iran. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Najmeh Hejazi, Ph.D (n20hejazi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay in ICU (time frame: day 28). The study lists 3 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 28 Jun 2013.