Non Alcoholic Fatty Liver Disease (NAFLD)Phase 1/2NCT02201160
Potential Role of n-3 Fatty Acids in the Treatment of NAFLD in Pediatric Patients
A Phase 1/2 study testing omega 3 in people with Non Alcoholic Fatty Liver Disease (NAFLD), run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and finally a progression to cirrhosis, sometimes… Read more about this study
- Who is it for?
- Ages 8 to 18 years, men only
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- omega 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Dec 2015
- Phase
- Phase 1/2
- 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 8 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- boys (according to the literature review on NAFLD prevalence)
- body weight ≥ 95th percentile (based on the CDC Chart)
- aged <18 years
- have a diffusely hyperechogenic liver at ultrasonography (consistent with NAFLD diagnostic)
- have normal or high transaminases (> 2N).
Who cannot join
- Subjects with pin or cochlear implants
- Subjects who consumed natural medicine products
- Those in whom a surgical procedure was planned
- the child who were found to consume fish, flaxseed oil and foods enriched with n-3 PUFA (eggs, or milk containing n-3 PUFA supplements), probiotics, vitamin E or use of drugs known to induce fatty liver during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of n-3 Fatty Acid Supplementation on the Metabolic Abnormalities in Children With NAFLD
Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and finally a progression to cirrhosis, sometimes accompanied by complications of hepatocellular carcinoma. It is a common condition associated with a combination of disorders, namely obesity, insulin resistance and type 2 diabetes. The link with the metabolic syndrome (MetS) was mainly studied in the adult population and very little in the paediatric population, while 15 and 25% of obese children are affectés. The severity of histological disease appears to be associated with the degree of obesity in children and particularly in the MetS. in addition, epidemiological data indicate that the incidence of this disease is increasing in children and positioning as the first NASH liver disease in North America. the revelation of the factors associated with the occurrence of NASH is a first necessary step to understanding this disorder worrying for the future of children and adolescents. In addition, clarification of the mechanisms responsible for its development is essential if the investigators want to consider targeted and effective treatments to slow the rat race of NASH, which stands out as the supreme chronic liver accompanying the obesity and MetS. Finally, in view of growth and puberty of children, it would be extremely beneficial to find nutritional avenues that would avoid the side effects of chemical agents.
Read the detailed description
The aims of the investigators studies are to determine the plasma FA composition and to assess changes in the latter in response to n-3 supplementation in French-Canadian youth since (i) none of the available pharmacological agents could be recommended for treatment of children with NAFLD; (ii) n-3 PUFA are quite safe diet supplements that showed efficacy in the prevention and therapy of cardiovascular diseases, dyslipidemia and metabolic syndrome; (iii) loss of n-3 PUFA dietary intake was found in pediatric NAFLD and (iii) no attention has been given to French-Canadian population, which is primarily and historically located in the province of Quebec, has the highest prevalence worldwide of lipoprotein lipase deficiency, includes a large pool of individuals at risk for atherosclerosis and other lipid-related diseases, and exhibits a founder effect among the 8,000 ancestors of present-day French-Canadians, who have had relatively little cross-breeding with individuals from other national origin groups.
Subjects The present randomized clinical trial was performed on 30 NAFLD children followed as outpatients at the Gastroenterology/Hepatology and Nutrition clinic of MCHU Ste-Justine and the Gastroenterology division of the Montreal Children's Hospital, Montreal.
The children have between 8 years and 18 years of age, with obesity and a diagnostic of NAFLD based on the results of a clinical evaluation, liver echography, and magnetic resonance imaging-proton density fat fraction.
Inclusion and exclusion criteria The children are eligible for the study if they are boys (according to the literature review on NAFLD prevalence), with a body weight ≥ 95th percentile (based on the CDC Chart), aged <18 years, have a diffusely hyperechogenic liver at ultrasonography (consistent with NAFLD diagnostic), and have normal or high transaminases (> 2N). Moreover, the exclusion criteria is based on subjects having pin or cochlear implants may affect the magnetic resonance imaging examination; subjects who consumed natural medicine products have an increased risk of haemorrhage, and those in whom a surgical procedure was planned, and the child who founded to consume fish, flaxseed oil and foods enriched with n-3 PUFA (eggs, or milk containing n-3 PUFA supplements), probiotics, vitamin E or use of drugs known to induce fatty liver during the study.
Study design The present study is a 6-month, double-blind, one-way, crossover randomized study. The treatment consisting of n-3 PUFA supplement (NutriSanté Inc./Ponroy, Canada), administered in two phases, each of 3-month duration. In the first phase, an NAFLD group will receive an active n-3 PUFA supplement and another will receive equivalent quantities of sunflower oil as a placebo. During the second phase (after the first 3 months), all NAFLD subjects will receive an active n-3 PUFA. The study is approved by the Clinical Research Ethics Committee of MUCH Ste-Justine (Montreal, Quebec. Informed consent was obtained from all subjects before starting experimental procedures, and the study followed the Helsinki guidelines.
Dosing The dose supplementation considered for this study is 2.0 g of fish oil per day, providing a total of 1.2 g of n-3 PUFA. This dose is chosen according to official recommendations, based on our previous studies and pediatric clinical trials. Compliance to the study treatment will be evaluated by pill count at every visit, review of medication records, and direct interview of patients by the physician.
- Being tested
- omega 3
- Keywords
- NAFLD, Fatty acid composition, Omega 3 supplementation, Metabolism
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3Dietary supplement
Two groups from our cohort will be supplemented either with omega-3 PUFA or placebo during 3 months. Each subject will take 4 capsules/d. after 3 months, the subjects under omega-3 will continue for another 3 months and the group under placebo will take omega-3 PUFA during another 3 months.
| Study group | Role | What they receive |
|---|---|---|
| omega 3 | Active comparator | The subjects will take 4 capsules/day during 6 months. Each capsule of the active n-3 PUFA supplement contained 500 mg of fish oil (each capsule provides 300 mg of n-3 PUFA (EPA+DHA) with 3.75 U vitamin E to prevent peroxidation). Receives: Dietary Supplement: omega 3 |
| Sun Flower | Placebo comparator | The subjects will take 4 capsules/day during 6 months. The placebo capsule contained 500 mg of sunflower oil with 3.75 U vitamin E. Receives: Dietary Supplement: omega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of omega 3 PUFA supplementation in NAFLD subjects compared to placebos
Two groups from our cohort will be double blind supplemented either with n-3 PUFA or sun flower (as a placebo).
The specific primary outcome is to assess the activities of hepatic plasma transaminase enzymes (ALT/AST/GGT) in the omega 3 group and to determine their decrease to the normal range.
Measured: 24 weeks
Secondary outcomes (1)
A composite mesures regarding the improvement of metabolic profile of NAFLD patients
To determine
- the decrease in obesity (body mass index)
- insulin resistance (HOMA-IR)
- Adipose tissue lowering (DEXA)
- Oxidative stress (Malondialdehyde biomarker, oxLDL) Inflammation (TNFalpha, IL-6, leptin and resistine)
- Plasma lipids (triglycerides, total cholesterol, LDL and HDL cholesterol)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic Fatty Liver Disease (NAFLD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrisanté Canada
- Responsible party
- Principal investigator, Emile Levy, St. Justine's Hospital
- Investigators
- Emile Levy, Professor, Principal investigator, Research Centre, CHU STe-Justine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201160
- Sponsor's protocol ID
- NAFLD-2188
- Status last verified
- Jul 2014
- First submitted
- 18 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belanger SA, Vanasse M, Spahis S, Sylvestre MP, Lippe S, L'heureux F, Ghadirian P, Vanasse CM, Levy E. Omega-3 fatty acid treatment of children with attention-deficit hyperactivity disorder: A randomized, double-blind, placebo-controlled study. Paediatr Child Health. 2009 Feb;14(2):89-98. doi: 10.1093/pch/14.2.89.
PubMed 19436468Spahis S, Alvarez F, Ahmed N, Dubois J, Jalbout R, Paganelli M, Grzywacz K, Delvin E, Peretti N, Levy E. Non-alcoholic fatty liver disease severity and metabolic complications in obese children: impact of omega-3 fatty acids. J Nutr Biochem. 2018 Aug;58:28-36. doi: 10.1016/j.jnutbio.2018.03.025. Epub 2018 Apr 10.
PubMed 29864682
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of n-3 Fatty Acid Supplementation on the Metabolic Abnormalities in Children With NAFLD
- ClinicalTrials.gov ID
- NCT02201160
- Acronym / sponsor ID
- NAFLD-2188
- Keywords
- NAFLD, Fatty acid composition, Omega 3 supplementation, Metabolism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Nutrisanté Canada
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Jul 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.
Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and finally a progression to cirrhosis, sometimes accompanied by complications of hepatocellular carcinoma. It is a common condition associated with a combination of disorders, namely obesity, insulin resistance and type 2 diabetes. The link with the metabolic syndrome (MetS) was mainly studied in the adult population and very little in the paediatric population, while 15 and 25% of obese children are affectés. The severity of histological disease appears to be associated with the degree of obesity in children and particularly in the MetS. in addition, epidemiological data indicate that the incidence of this disease is increasing in children and positioning as the first NASH liver disease in North America. the revelation of the factors associated with the occurrence of NASH is a first necessary step to understanding this disorder worrying for the future of children and adolescents. In addition, clarification of the mechanisms responsible for its development is essential if the investigators want to consider targeted and effective treatments to slow the rat race of NASH, which stands out as the supreme chronic liver accompanying the obesity and MetS. Finally, in view of growth and puberty of children, it would be extremely beneficial to find nutritional avenues that would avoid the side effects of chemical agents.
Detailed description
The aims of the investigators studies are to determine the plasma FA composition and to assess changes in the latter in response to n-3 supplementation in French-Canadian youth since (i) none of the available pharmacological agents could be recommended for treatment of children with NAFLD; (ii) n-3 PUFA are quite safe diet supplements that showed efficacy in the prevention and therapy of cardiovascular diseases, dyslipidemia and metabolic syndrome; (iii) loss of n-3 PUFA dietary intake was found in pediatric NAFLD and (iii) no attention has been given to French-Canadian population, which is primarily and historically located in the province of Quebec, has the highest prevalence worldwide of lipoprotein lipase deficiency, includes a large pool of individuals at risk for atherosclerosis and other lipid-related diseases, and exhibits a founder effect among the 8,000 ancestors of present-day French-Canadians, who have had relatively little cross-breeding with individuals from other national origin groups.
Subjects The present randomized clinical trial was performed on 30 NAFLD children followed as outpatients at the Gastroenterology/Hepatology and Nutrition clinic of MCHU Ste-Justine and the Gastroenterology division of the Montreal Children's Hospital, Montreal.
The children have between 8 years and 18 years of age, with obesity and a diagnostic of NAFLD based on the results of a clinical evaluation, liver echography, and magnetic resonance imaging-proton density fat fraction.
Inclusion and exclusion criteria The children are eligible for the study if they are boys (according to the literature review on NAFLD prevalence), with a body weight ≥ 95th percentile (based on the CDC Chart), aged <18 years, have a diffusely hyperechogenic liver at ultrasonography (consistent with NAFLD diagnostic), and have normal or high transaminases (> 2N). Moreover, the exclusion criteria is based on subjects having pin or cochlear implants may affect the magnetic resonance imaging examination; subjects who consumed natural medicine products have an increased risk of haemorrhage, and those in whom a surgical procedure was planned, and the child who founded to consume fish, flaxseed oil and foods enriched with n-3 PUFA (eggs, or milk containing n-3 PUFA supplements), probiotics, vitamin E or use of drugs known to induce fatty liver during the study.
Study design The present study is a 6-month, double-blind, one-way, crossover randomized study. The treatment consisting of n-3 PUFA supplement (NutriSanté Inc./Ponroy, Canada), administered in two phases, each of 3-month duration. In the first phase, an NAFLD group will receive an active n-3 PUFA supplement and another will receive equivalent quantities of sunflower oil as a placebo. During the second phase (after the first 3 months), all NAFLD subjects will receive an active n-3 PUFA. The study is approved by the Clinical Research Ethics Committee of MUCH Ste-Justine (Montreal, Quebec. Informed consent was obtained from all subjects before starting experimental procedures, and the study followed the Helsinki guidelines.
Dosing The dose supplementation considered for this study is 2.0 g of fish oil per day, providing a total of 1.2 g of n-3 PUFA. This dose is chosen according to official recommendations, based on our previous studies and pediatric clinical trials. Compliance to the study treatment will be evaluated by pill count at every visit, review of medication records, and direct interview of patients by the physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega 3 | Active comparator | Dietary Supplement: omega 3The subjects will take 4 capsules/day during 6 months. Each capsule of the active n-3 PUFA supplement contained 500 mg of fish oil (each capsule provides 300 mg of n-3 PUFA (EPA+DHA) with 3.75 U vitamin E to prevent peroxidation). |
| Sun Flower | Placebo comparator | Dietary Supplement: omega 3The subjects will take 4 capsules/day during 6 months. The placebo capsule contained 500 mg of sunflower oil with 3.75 U vitamin E. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- boys (according to the literature review on NAFLD prevalence)
- body weight ≥ 95th percentile (based on the CDC Chart)
- aged <18 years
- have a diffusely hyperechogenic liver at ultrasonography (consistent with NAFLD diagnostic)
- have normal or high transaminases (> 2N).
Key exclusion criteria (4 listed)
- Subjects with pin or cochlear implants
- Subjects who consumed natural medicine products
- Those in whom a surgical procedure was planned
- the child who were found to consume fish, flaxseed oil and foods enriched with n-3 PUFA (eggs, or milk containing n-3 PUFA supplements), probiotics, vitamin E or use of drugs known to induce fatty liver during the study.
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 |
|---|---|---|
| omega 3Two groups from our cohort will be supplemented either with omega-3 PUFA or placebo during 3 months. Each subject will take 4 capsules/d. after 3 months, the subjects under omega-3 will continue for another 3 months and the group under placebo will take omega-3 PUFA during another 3 months. | Dietary supplement | Sun Flower, omega 3 |
Primary outcome
Efficacy of omega 3 PUFA supplementation in NAFLD subjects compared to placebos
Time frame: 24 weeks
Two groups from our cohort will be double blind supplemented either with n-3 PUFA or sun flower (as a placebo). The specific primary outcome is to assess the activities of hepatic plasma transaminase enzymes (ALT/AST/GGT) in the omega 3 group and to determine their decrease to the normal range.
1 secondary outcome
A composite mesures regarding the improvement of metabolic profile of NAFLD patients
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Background: PubMed 19436468Belanger SA, Vanasse M, Spahis S, Sylvestre MP, Lippe S, L'heureux F, Ghadirian P, Vanasse CM, Levy E. Omega-3 fatty acid treatment of children with attention-deficit hyperactivity disorder: A randomized, double-blind, placebo-controlled study. Paediatr Child Health. 2009 Feb;14(2):89-98. doi: 10.1093/pch/14.2.89.
- Derived from this study: PubMed 29864682Spahis S, Alvarez F, Ahmed N, Dubois J, Jalbout R, Paganelli M, Grzywacz K, Delvin E, Peretti N, Levy E. Non-alcoholic fatty liver disease severity and metabolic complications in obese children: impact of omega-3 fatty acids. J Nutr Biochem. 2018 Aug;58:28-36. doi: 10.1016/j.jnutbio.2018.03.025. Epub 2018 Apr 10.
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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.
Emile Levy, Professor principal investigator
Research Centre, CHU STe-Justine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing omega 3 in people with Non Alcoholic Fatty Liver Disease (NAFLD), run by St. Justine's Hospital 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 5 inclusion and 4 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 25 Jul 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 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Efficacy of omega 3 PUFA supplementation in NAFLD subjects compared to placebos (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201160, which also lists 2 linked publications.
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 25 Jul 2014.