Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0672184850
Study information
Scientific title
A Prospective, Randomised, Double Blind, Placebo Controlled Group Study Of The Benefits Of Omega 3 Fish Oils (Concentrated Fish Oils 500 milligrams) In Children Between the Ages Of 11-16 Years
Acronym
Study hypothesis
Can Omega 3 Fish Oil (concentrated fish oils 500 milligrams) improve the cognitive function of school age children with moderate to severe learning difficulties in the age range of 11-16 years?
Ethics approval
Not provided at time of registration
Study design
Prospective randomised double-blind placebo-controlled group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Supplements
Intervention
The potential participants of this study are already under the care of the investigators, whether this is from a Health or Educational perspective. This aspect is of great importance as there is no intervention from anyone who is unfamiliar. It is also routine that any medications the children require are administered by designated teachers at the school. The methodology to be used in this study permits this routine to be maintained.
The parent/s and or guardians of all children in years 6 to 11 (ages 11-16 years) attending Cambridge Park Special School in Grimsby will be invited to attend one of a number of meetings in early September at which the study will be explained to parents / guardians. For those parents / guardians who can not attend any of the school meetings a member of the CPS teaching team will make a home visit to inform them of the study. Home visits to parents / guardians is routine at CPS. Following the meetings parents / guardians will be approached and again with verbal along with written study information being provided to them. Parent/s and or guardians will be given one week to decide whether they wish their child can participate or not. If they decide yes, then they will be asked to sign a consent form. However, they will be reassured that they are free to withdraw their consent at any time without giving a reason. Additionally, they will be informed that the investigators may withdraw their child from the study if that is regarded as in the child's best interests.
If at all possible children will also be asked to agree their participation, although realistically this will probably only be feasible in a few children.
To help raise the awareness of parents that the study is planned, a number of posters will be displayed in the reception area of the school. As a routine part of the schools cycle of testing, each child is tested at school in June /July of each year. This has already been undertaken at Cambridge Park Special School. Only once consent has been obtained, will these test results will be included as part of this study for those children whose parents / guardians have provided consent. The tests are as follows:
1. Youngs Reading test
2. Youngs Maths Tests
3. Schonell Group Spelling Test
4. Nelson Insight Self Esteem Test.
Following this, children will be match paired. Matched pairing will be carried out by the Educational psychologist. Great care will be taken to ensure that the matching process will consider all aspects and in particular, for age, sex, socio-economic status and ability.
Once the pre-assessments have been completed, children in matched pairs will be randomised to either Fish Oil or Placebo Resulting in one child in the matched pair receiving the fish oil (500 milligrams in two small capsules) and the other receiving the placebo. Randomisation will be computer generated using the Statistical Package for Social Services (SPSS). The randomised intervention will be written on paper and placed in envelopes in numerical order. The envelopes which will be used in numerical order will be kept securely in the office of the Head Teacher at Cambridge Park Special School. Once a randomisation number has been allocated, the participants will only be identified by that number for the duration of the study and will only receive the allocated intervention. For the purpose of code breaking, a master copy of the randomisation will be kept securely by the Northern Lincolnshire & Goole Hospitals NHS Trust (NL&G) Research & Development Department (R&D) and in a sealed envelope by the head teacher at CPS in the event that the R&D Department can not be contacted. This copy will only be opened if there is no other alternative.
The placebo and the fish oil will be offered as two small capsules which will be indistinguishable from each other by external appearances, smell or taste and will be produced and provided free of charge by the manufacturer, Croda Chemicals Europe Ltd. Croda Health Care.
Administration of the fish oils / placebo (two small capsules) will be in school (Monday - Friday) on a daily basis and in term time only. During half term, school holidays and weekends it will not be administered. This is to reduce the element of chance. If parent/s guardians were asked to administer the fish oils / placebo an element of non-compliance may result which has the potential to skew or invalidate the results. If a child has a protracted absence, defined as five consecutive days or longer, from school they will be withdrawn from the study as a protocol violation.
As routine the tests as identified above will be repeated towards the end of the school year.
The total duration of the study will be up to 9 months. Following the second set of testing the two sets of test results will be analysed. The Omega3 / Placebo will be administered by trained members of CPS school staff, who routinely administer medicines. This will be conducted in accordance with the school policy. As routine all medications which are administered at school are recorded on a dedicated medicines chart. The same chart will be used for this study intervention and will be colour co-ordinated with the labels of the containers of Omega 3 / Placebo. All medicine charts will, as routine be kept in a locked filing cabinet in the head teachers office. Only the head teacher and the trained CPS staff will have access to the charts.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Analysis by significance testing (t-Test) Chi-square test and Mantel-Haenszel Test for a matched pairing, log transformation and McNemar Test. The difference between the response of the 2 units in each matched pair besides the difference of each unit's own individual response are analysed.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/09/2006
Overall trial end date
30/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
The sample will be one of convenience. There are approximately 100 children attending the school who may be eligible. Children will be regarded as eligible to participate in the study if all of the following criteria are met:
Assuming that participants will not be Gillick competent:
1. Their parent/s and or guardian agree to their child's participation and will provide a written informed consent
2. Must be attending Cambridge Park Special School in Grimsby
3. Their parent/s and or guardian agree to their child receiving the dietary supplement at school and during school term times
4. If and wherever possible, the child's agreement to participate will be obtained
5. The child is physically able to swallow intact encapsulated fish oil.
6. The child has no known allergies to fish oils
7. The child has no known allergies to the placebo
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant exclusion criteria
Children will be not be regarded as eligible to participate in the study if any of the following criteria are apply:
Assuming that participants will not be Gillick competent
1. Their parent/s and or guardian do not agree to their child's participation and will not provide a written informed consent
2. Children whose parents request them to be given Omega 3 only
3. Not attending Cambridge Park Special School in Grimsby
4. Their parent/s and or guardian do not agree to their child receiving the dietary supplement at school and during school term times
5. The child is not physically able to swallow intact encapsulated fish oil.
6. The child has known allergies to fish oils
7. The child has known allergies to the placebo
8. The child is known to be un-cooperative
9. Children known to be already taking fish oil food supplement
Recruitment start date
11/09/2006
Recruitment end date
30/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Diana Princess of Wales Hospital
Grimsby
DN33 2BA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northern Lincolnshire and Goole Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Croda Health Care provides fish oil capsules and the placebo free of charge
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary