Status:
RECRUITING
Poly-unsaturated Fatty Acids and Developmental Dyslexia
Lead Sponsor:
IRCCS Eugenio Medea
Collaborating Sponsors:
University of Milan
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Dyslexia, Developmental
Eligibility:
All Genders
7-15 years
Phase:
NA
Brief Summary
Poly-unsaturated fatty acids (PUFAs) represent a component of lipids that covers a relevant role in human diet and biological functions such as provision of energy, functionality of cell membranes and...
Eligibility Criteria
Inclusion
- Inclusion Criteria for DD participants will be:
- A formal diagnosis of Developmental Dyslexia, Specific Reading Disorders or Mixed Learning Disorders
- Age between 7 and 15
- Attending at least the third class of primary school
- Monolingual speakers or bilingual speakers with perfect mastery of the Italian language (equivalent to monolinguals)
- Intelligence Quotient (IQ) \>= 80
- At least one z-score below -2 Standard Deviations from age mean in at least one of the following tests: text reading, word reading, nonword reading (Dyslexia and Dysorthography (DDE-2) battery, Memory Training (MT) tests)
- Not having received any specific rehabilitation treatment for dyslexia before
- Inclusion criteria for control participants will be:
- Age between 7 and 15
- Attending at least the third class of primary school
- Monolingual speakers or bilingual speakers with perfect mastery of the Italian language (equivalent to monolinguals)
- no reported record of difficulties with reading nor specific learning disorders
- Intelligence Quotient (IQ) \>= 80
- No z-score below -1,5 Standard Deviations from age mean in any of the following tests: text reading, word reading, nonword reading ("DDE-2" battery, "MT" tests)
- Exclusion Criteria:
- Intellectual disability
- Attention Deficit with Hyperactivity (ADHD)
- Neurological disorders
- Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearing aids.
- Allergy to fish and shellfish
- Absorption Disorders (malabsorption)
- Children already (or recently) on a diet with PUFA supplementation
- Children on a therapy with psychoactive medications (anti-depressant, anxiety-control etc.) or with supplements who have not reached a stable administration schedule.
Exclusion
Key Trial Info
Start Date :
May 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04287530
Start Date
May 2 2020
End Date
February 1 2025
Last Update
March 22 2024
Active Locations (2)
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1
IRCCS "E. Medea" - La Nostra Famiglia
Bosisio Parini, (LC), Italy, 23842
2
IRCCS E.Medea, polo di Conegliano
Conegliano, TV, Italy