| Trial ID: | L0655 |
| Source ID: | EUCTR2012-001975-36-IT
|
| Associated Drug: |
Docosahexaenoic acid
|
| Title: |
Evaluation on the efficacy of docosahexaenoic acid for the treatment of nonalcoholic fatty liver disease in children - DHA for fatty liver in children
|
| Acronym: |
--
|
| Status: |
Authorised
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic steatohepatitis <br>MedDRA version: 14.1
Level: SOC
Classification code 10027433
Term: Metabolism and nutrition disorders
System Organ Class: 10027433 - Metabolism and nutrition disorders
;Therapeutic area: Diseases [C] - Nutritional and Meta
|
| Interventions: |
<br>Product Name: DHA<br>Product Code: NA<br>Pharmaceutical Form: Chewable capsule, soft<br>Current Sponsor code: A<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 250-<br>Pharmaceutical form of the placebo: Ch
|
| Outcome Measures: |
Main Objective: To evaluate wether DHA suppementation decreases fatty liver content in children with NAFLD;Secondary Objective: To evaluate wether DHA suppementation improves liver function as well as the insulinresistance;Primary end point(s): Reduction of hepatic fat content;Timepoint(s) of evaluation of this end point: six monthsSecondary end point(s): improvement of liver and metabolic functions;Timepoint(s) of evaluation of this end point: three and six months
|
| Sponsor/Collaborators: |
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
--
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
|
| Start Date: |
14/06/2012
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 January 2013
|
| Locations: |
Italy
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001975-36
|
