ISRCTN54901093CompletedNot Applicable
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
Record Provided by the NHSTCT Register - 2007 Update - Department of Health0 sites100 target enrollmentStarted: September 28, 2007Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
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
Investigators
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