Home » Trials » SLCTR/2009/006
Effectiveness of Omega-3 and Omega-6 in children with neuro-developmental disorders: a double-blind placebo-controlled study
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SLCTR Registration Number
SLCTR/2009/006
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Effectiveness of Omega-3 and Omega-6 in children with neuro-developmental disorders: a double-blind placebo-controlled study
Public Title of Trial
Effectiveness of Omega-3 and Omega-6 in childhood behaviour disorders
Disease or Health Condition(s) Studied
Attention deficit hyperactivity disorder,autism,disruptive behaviour disorders such as oppositional defiant disorders and conduct disorders ,specific learning disorders
Scientific Acronym
None
Public Acronym
None
Brief title
Effectiveness of combined omega-3 and omega-6 in childhood behaviour disorders
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
LRH/D/6/2009 (Ethics Review Committee of the Lady Ridgeway Hospital, Colombo)
What is the research question being addressed?
The primary aim of the study is to evaluate whether combined omega-3 and omega-6 is effective as an adjunct treatment in children with neuro-developmental disorders who show partial or unsatisfactory response to pharmacological and non-pharmacological methods. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
Omega-3 & 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.
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.
Primary outcome(s)
|
1.
Outcome will be measured at one month, three months and six months after the onset of treatment. Tools of assessment: 1.Diagnosis of behaviour disorder will be made using DSM IV TR criteria. Comorbid disorders will be similarly diagnosed. 2. SNAP IV completed by parent and teacher will be used to further validate the diagnosis and assess the severity of the symptoms. SDQ will be used to assess the specific symptoms of ADHD and its impact. 3. SNAP IV and SDQ will be used to objectively assess the outcome in 1 month, 3 months and 6 months in addition to the clinical assessment. 4. Structured psychometric assessments will be used to evaluate any learning difficulties in the child. 5. A clinical assessment will be made to gather information from parents regarding their perception of child’s behaviour and level of satisfaction with treatment. 6. A semi-structured questionnaire will be used to record bio-data and other patient and family related information |
[ At 1 month, 3 months and 6 month after commencement of treatment ] |
Secondary outcome(s)
|
1.
Asses for side effects such as tolerance |
[ At 1 month, 3 months and 6 month after commencement of treatment ] |
Target number/sample size
100 (50 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2009-10-05
Anticipated end date
2010-04-05
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Igennus Ltd, Cambridge, UK / Gpristine (private) limited , Srilanka
Regulatory approvals
Status
Approved
Date of Approval
2009-02-02
Approval number
LRH/D/06/2009
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Lady Ridgeway Hospital, Colombo |
| Institutional Address: | Dr. Denister De Silva Mawatha, Colombo 0800, Sri Lanka |
| Telephone: | Not Available |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
Hemamali Perera
Professor in Psychological Medicine
Department of Psychological Medicine, Faculty of Medicine , Kynsey Road , Colombo 8
+94777354616
hemamali_p@yahoo.com
Contact Person for Public Queries
Hemamali Perera
Professor in Psychological Medicine
Department of Psychological Medicine, Faculty of Medicine , Kynsey Road , Colombo 8
+94777354616
hemamali_p@yahoo.com
Primary study sponsor/organization
Habib Jaleel
Gpristine (Private limited)
+94772305051
habibjaleel@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
