HIV InfectionsPhase 2NCT00152815
Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
A Phase 2 study testing antioxidant vitamin E and weight reduction and exercise in people with HIV Infections and Fatty Liver, run by Johane Allard at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Fatty Liver
- What is being tested?
- antioxidant vitamin E and weight reduction and exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2003to Dec 2010
- Phase
- Phase 2
- 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
- Baseline liver biopsy with macrovesicular fatty degeneration with inflammation (lobular or portal), with or without Mallory bodies, hepatocyte damage, and/or fibrosis diagnostic of NAFLD
- Convincing evidence of negligible alcohol consumption (< 20 grams of ethanol per day) obtained from a detailed history, confirmed by at least one close relative
- If hyperlipidemia or diabetes, stable drug regimen required for the 6 months prior to and during the study
- Willingness to maintain stable weight and normal exercise program for the duration of the study, if randomized to vitamin E or betaine
Who cannot join
- Liver disease of other etiology diagnosed as per routine medical investigation (e.g., chronic viral hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis or genetic liver disease such as Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, or biliary obstruction)
- Complications of liver disease such as recurrent variceal bleeding, resistant ascites, spontaneous portosystemic encephalopathy, or bacterial peritonitis
- Concurrent medical illness contra-indicating a liver biopsy, history of unexplained bleeding, hemophilia or abnormal coagulation results as per routine laboratory work-up or other reason judged by the hepatologist to contra-indicate a percutaneous liver biopsy
- Medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen, oxacillin or ampinovire) in the 6 months prior to entry
- Antioxidant vitamin supplementation, ursodeoxycholic acid, or any other experimental drug 6 months prior to study entry
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.
- Conditions
- HIV Infections, Fatty Liver
- Being tested
- antioxidant vitamin E, weight reduction and exercise
- Keywords
- HIV, non-alcoholic fatty liver disease
- Medical subject headings
- HIV Infections, Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antioxidant vitamin EDrug
Vitamin E 800IU per day for 12 months
weight reduction and exerciseBehavioural
Also called This arm was removed from the study protocol, as the enrollment was slow and, a high drop-out rate was observed in the weigh-loss arm
Patients will be asked to consume a self-selected, low fat, low-calorie diet of approximately 1200 kcal/d, which is consistent with American Heart Association guidelines for healthy weight reduction. Subjects will be provided with a videotape involving a structured 20 min aerobic exercise to be performed 3x/week.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E | Experimental | alpha-tocoperol, capsules, 2 per day Receives: Drug: antioxidant vitamin E; Behavioral: weight reduction and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study
Measured: month 0 and month 12
Secondary outcomes (8)
Liver histology for steatosis and fibrosis staging
Measured: month 0 and month 12
Liver immuno-histochemistry for adducts of MDA: a product of LP
Measured: month 0 and month 12
Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation
Measured: month 0 and month 12
Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis
Measured: month 0 and month 12
Liver lipid peroxides and TNP-alpha
For oxidative stress and inflammation in the liver
Measured: month 0, month 6 and month 12
Liver steatosis and volume will be assessed by ultrasound
Measured: month 0 and month 12
Liver enzymes and IR (HOMA and QUICKY) will also be measured
Measured: month 0, month 6 and month 12
Lipid peroxides, TNF-alpha, vitamin E and C in plasma
Parameters for oxidative stress and antioxidant capacity
Measured: month 0, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Not enough eligible patients available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johane Allard
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario HIV Treatment Network
- Responsible party
- Sponsor-investigator, Johane Allard, University Health Network, Toronto
- Investigators
- Allard Johane, MD, FRCPC, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152815
- Sponsor's protocol ID
- 03-0297-B
- Other IDs
- ROGB139
- Status last verified
- Jul 2013
- First submitted
- 7 Sep 2005
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
- ClinicalTrials.gov ID
- NCT00152815
- Acronym / sponsor ID
- 03-0297-B
- Conditions
- HIV Infections, Fatty Liver
- Keywords
- HIV, non-alcoholic fatty liver disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough eligible patients available
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johane AllardUniversity, hospital or other
- Collaborators
- Ontario HIV Treatment Network
- Study start
- Oct 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Sep 2005 (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 purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin E | Experimental | Drug: antioxidant vitamin E, Behavioral: weight reduction and exercisealpha-tocoperol, capsules, 2 per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Baseline liver biopsy with macrovesicular fatty degeneration with inflammation (lobular or portal), with or without Mallory bodies, hepatocyte damage, and/or fibrosis diagnostic of NAFLD
- Convincing evidence of negligible alcohol consumption (< 20 grams of ethanol per day) obtained from a detailed history, confirmed by at least one close relative
- If hyperlipidemia or diabetes, stable drug regimen required for the 6 months prior to and during the study
- Willingness to maintain stable weight and normal exercise program for the duration of the study, if randomized to vitamin E or betaine
Key exclusion criteria (6 listed)
- Liver disease of other etiology diagnosed as per routine medical investigation (e.g., chronic viral hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis or genetic liver disease such as Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, or biliary obstruction)
- Complications of liver disease such as recurrent variceal bleeding, resistant ascites, spontaneous portosystemic encephalopathy, or bacterial peritonitis
- Concurrent medical illness contra-indicating a liver biopsy, history of unexplained bleeding, hemophilia or abnormal coagulation results as per routine laboratory work-up or other reason judged by the hepatologist to contra-indicate a percutaneous liver biopsy
- Medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen, oxacillin or ampinovire) in the 6 months prior to entry
- Antioxidant vitamin supplementation, ursodeoxycholic acid, or any other experimental drug 6 months prior to study entry
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 |
|---|---|---|
| antioxidant vitamin EVitamin E 800IU per day for 12 months | Drug | Vitamin E |
| weight reduction and exerciseAlso: This arm was removed from the study protocol, as the enrollment was slow and, a high drop-out rate was observed in the weigh-loss armPatients will be asked to consume a self-selected, low fat, low-calorie diet of approximately 1200 kcal/d, which is consistent with American Heart Association guidelines for healthy weight reduction. Subjects will be provided with a videotape involving a structured 20 min aerobic exercise to be performed 3x/week. | Behavioural | Vitamin E |
Primary outcome
The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study
Time frame: month 0 and month 12
8 secondary outcomes
Liver histology for steatosis and fibrosis staging
Time frame: month 0 and month 12
Liver immuno-histochemistry for adducts of MDA: a product of LP
Time frame: month 0 and month 12
Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation
Time frame: month 0 and month 12
Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis
Time frame: month 0 and month 12
Liver lipid peroxides and TNP-alpha
Time frame: month 0, month 6 and month 12
Liver steatosis and volume will be assessed by ultrasound
Time frame: month 0 and month 12
Liver enzymes and IR (HOMA and QUICKY) will also be measured
Time frame: month 0, month 6 and month 12
Lipid peroxides, TNF-alpha, vitamin E and C in plasma
Time frame: month 0, month 6 and month 12
Results and safety
The study was stopped early (reason given: Not enough eligible patients available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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.
Allard Johane, MD, FRCPC principal investigator
University Health Network, Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing antioxidant vitamin E and weight reduction and exercise in people with HIV Infections and Fatty Liver, run by Johane Allard at 1 site in Canada.
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 4 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: stopped early, as of the sponsor's last update on 19 Jul 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough eligible patients available). Results are not available in the source record.
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?
The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study (time frame: month 0 and month 12). 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 Jul 2013.