NAFLDPhase 3VitD_DHANCT02098317
DHA and Vitamin D in Children With Biopsy-proven NAFLD
A Phase 3 study testing DHA plus Vitamin D in people with NAFLD and Non Alcoholic Steatohepatitis (NASH), run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- NAFLD, Non Alcoholic Steatohepatitis (NASH)
- What is being tested?
- DHA plus Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Sep 2015
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- biopsy consistent with the diagnosis of NAFLD/NASH
- reduced serum levels of vitamin D aminotransferases (ALT) levels <10 upper limit of normal
- hyperechogenicity at liver ultrasound examination suggestive of fatty liver
- International normalized ratio (INR) < 1,3
- Albumin > 3 g/dl
- total bilirubin < 2,5 mg/dl
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- no previous gastrointestinal bleeding
- no previous portosystemic encephalopathy
- normal renal function
- no hepatitis B, hepatitis C infection
- normal cell blood count
Who cannot join
- alcohol consumption
- use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
- autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease
- every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
- finding of active liver disease due to other causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression.
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven nonalcoholic fatty liver disease (NAFLD).
Read the detailed description
Sixty-six children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA and Vitamin D (n=33) or an identical placebo (n=33) given orally for a period of 6 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.
Patients will undergo a medical evaluation at 3-6 and 12 months during the 12-months study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric measurements and laboratory tests, including liver enzymes, gluco-insulinemic profile and lipids will be performed at baseline and repeated at 6-12 months
- Conditions
- NAFLD, Non Alcoholic Steatohepatitis (NASH)
- Being tested
- DHA plus Vitamin D, Placebo
- Keywords
- NAFLD, NASH, DHA, VITAMIN D, OBESITY, CHILDREN
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA plus Vitamin DDrug
DHA 500 mg plus Vitamin D 800 IU
PlaceboDrug
Placebo pearls mimicking pearls with DHA and Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| TREATED GROUP | Experimental | this group will treated with pearls containing DHA plus Vitamin D3 (500 mg and 800 IU, respectively) given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 24 weeks Receives: Drug: DHA plus Vitamin D |
| PLACEBO GROUP | Placebo comparator | this group will treated with identical placebo pearls given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in NAFLD Activity Score (NAS)
Measured: 12 months
Secondary outcomes (2)
improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile
Measured: at 6 and 12 months
safety
clinical examination, medical history and specific laboratory parameters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerio Nobili, Bambino Gesù Hospital and Research Institute
- Investigators
- Valerio Nobili, Professor, Principal investigator, Bambino Gesù Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098317
- Sponsor's protocol ID
- VD3_DHA_NAFLD
- Acronym
- VitD_DHA
- Status last verified
- Jan 2016
- First submitted
- 24 Mar 2014
- Last updated
- 14 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD
- ClinicalTrials.gov ID
- NCT02098317
- Acronym / sponsor ID
- VitD_DHA / VD3_DHA_NAFLD
- Conditions
- NAFLD, Non Alcoholic Steatohepatitis (NASH)
- Keywords
- NAFLD, NASH, DHA, VITAMIN D, OBESITY, CHILDREN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Mar 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.
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression.
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven nonalcoholic fatty liver disease (NAFLD).
Detailed description
Sixty-six children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA and Vitamin D (n=33) or an identical placebo (n=33) given orally for a period of 6 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.
Patients will undergo a medical evaluation at 3-6 and 12 months during the 12-months study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric measurements and laboratory tests, including liver enzymes, gluco-insulinemic profile and lipids will be performed at baseline and repeated at 6-12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TREATED GROUP | Experimental | Drug: DHA plus Vitamin Dthis group will treated with pearls containing DHA plus Vitamin D3 (500 mg and 800 IU, respectively) given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 24 weeks |
| PLACEBO GROUP | Placebo comparator | Drug: Placebothis group will treated with identical placebo pearls given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 24 weeks |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- biopsy consistent with the diagnosis of NAFLD/NASH
- reduced serum levels of vitamin D aminotransferases (ALT) levels <10 upper limit of normal
- hyperechogenicity at liver ultrasound examination suggestive of fatty liver
- International normalized ratio (INR) < 1,3
- Albumin > 3 g/dl
Key exclusion criteria (5 listed)
- alcohol consumption
- use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
- autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease
- every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
- finding of active liver disease due to other causes
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 |
|---|---|---|
| DHA plus Vitamin DDHA 500 mg plus Vitamin D 800 IU | Drug | TREATED GROUP |
| PlaceboPlacebo pearls mimicking pearls with DHA and Vitamin D | Drug | PLACEBO GROUP |
Primary outcome
Improvement in NAFLD Activity Score (NAS)
Time frame: 12 months
2 secondary outcomes
improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile
Time frame: at 6 and 12 months
safety
Time frame: 6 months
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 14 Jan 2016.
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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.
Valerio Nobili, Professor principal investigator
Bambino Gesù Children Hospital
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 DHA plus Vitamin D in people with NAFLD and Non Alcoholic Steatohepatitis (NASH), run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 11 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 14 Jan 2016. 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 Italy. 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?
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?
Improvement in NAFLD Activity Score (NAS) (time frame: 12 months). 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 14 Jan 2016.