|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
SLCTR |
|
Last refreshed on:
|
27 April 2013 |
|
Main ID: |
SLCTR/2009/006 |
|
Date of registration:
|
17/07/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Effectiveness of Omega-3 and Omega-6 in childhood behaviour disorders
|
|
Scientific title:
|
Effectiveness of Omega-3 and Omega-6 in children with neuro-developmental disorders: a double-blind placebo-controlled study |
|
Date of first enrolment:
|
5/10/2009 |
|
Target sample size:
|
100 children randomly selected will be included in the study, equally divided into study and control groups |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.slctr.lk/trial_details.asp?reg_id={07FD81F3-00B9-42D3-81D8-4B5749F56FAD} |
|
Study type:
|
Interventional |
|
Study design:
|
Double-blind placebo-controlled study
|
|
|
Countries of recruitment
|
|
Sri Lanka
| | | | | | | |
|
Contacts
|
|
Name:
|
Hemamali Perera
|
|
Address:
|
Department of Psychological Medicine, Faculty of Medicine , Kynsey Road , Colombo 8
|
|
Telephone:
|
+94777354616 |
|
Email:
|
hemamali_p@yahoo.com |
|
Affiliation:
|
Professor in Psychological Medicine |
|
|
Name:
|
Hemamali Perera
|
|
Address:
|
Department of Psychological Medicine, Faculty of Medicine , Kynsey Road , Colombo 8
|
|
Telephone:
|
+94777354616 |
|
Email:
|
hemamali_p@yahoo.com |
|
Affiliation:
|
Professor in Psychological Medicine |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: The sample will be selected from among children aged 6-12 years, diagnosed with ADHD. Children already on medication and those without medication will be included. Also, children with ADHD and other comorbid disorders (oppositional disorders, learning disability, tic disorder and autism) will be included
Exclusion criteria: Children with mental retardation as a primary diagnosis or as an associated condition will be excluded from the study.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Attention deficit hyperactivity disorder,autism,disruptive behaviour disorders such as oppositional defiant disorders and conduct disorders ,specific learning disorders
|
|
Intervention(s)
|
|
Omega-3 and omega-6 in the form of 280 mg of EPA and 100 mg of EPO in one capsule will be given twice a day. Any other medication the child is already taking will be continued as well as any non-pharmacological therapies.
|
|
Primary Outcome(s)
|
|
Improvement in symptoms of ADHD and its comorbid behaviour disorders as assessed by DSM IV TR criteria, SNAP IV and SDQ schedules completed by parent and teachers
|
|
Secondary Outcome(s)
|
Asses for side effects such as tolerance
|
|
Source(s) of Monetary Support
|
|
Igennus Ltd, Cambridge, UK / Gpristine (private) limited , Srilanka
|
|