Home » Trials » Trial #73 » original TRDS
SLCTR Registration Number
SLCTR/2009/006
Date of Registration
The date of last modification
Aug 05, 2012
View original TRDS
Scientific Title of Trial
Effectiveness of combined omega 3 & omega 6 in children with neuro-developmental disorders: an open trial
Public Title of Trial
Effectiveness of omega-3 & omega-6 in children with neuro-developmental disorders: an open trial
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
None
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
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Study Phase
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 6-10 years, diagnosed with neuro-developmental disorders (ADHD, autism, specific learning disorder and disruptive behaviour disorders). Children already on medication and / or other therapies will be included. Children with primary diagnosis of a neuro-developmental disorder but with other comorbid disorders will also be included in the study
Exclusion criteria
Children with mental retardation as a primary diagnosis or as an associated condition will be excluded from the study.
Primary outcome(s)
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1.
Out come of improved behaviour will be assessed using following standerdized tools 1.Diagnosis of individual neuro-developmental disorders to be tested 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 of ADHD and assess the severity of the symptoms. SDQ will be used to assess the specific symptoms of ADHD and its impact. 3. Autism will be diagnosed using DSM IV TR criteria. 4. Structured psychometric assessments will be used to evaluate specific learning disability. 5. SNAP IV and SDQ will be used to objectively assess the outcome in ADHD in 1 month, 3 months, in addition to the clinical assessment. 6. A structured questionnaires will be used and completed by mothers to gather data on outcome at 1 month and 3 months from parents and teachers regarding learning disorders and disruptive behaviour disorders 7. A semi-structured questionnaire will be used to record demographic and socio-cultural information |
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Secondary outcome(s)
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1.
Asses for side effects such as tolerance |
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Target number/sample size
50
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
Funding source
Igennus Ltd, Cambridge, UK / Gpristine (private) limited , Srilanka
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
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
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
