Last updated: March 20, 2024
Sponsor: IRCCS Eugenio Medea
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dyslexia
Treatment
Neuropsychological intervention
Poly-unsaturated fatty acids supplementation
Placebo
Clinical Study ID
NCT04287530
677
Ages 7-15 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria for DD participants will be:
- A formal diagnosis of Developmental Dyslexia, Specific Reading Disorders or MixedLearning 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 Italianlanguage (equivalent to monolinguals)
- Intelligence Quotient (IQ) >= 80
- At least one z-score below -2 Standard Deviations from age mean in at least one of thefollowing tests: text reading, word reading, nonword reading (Dyslexia andDysorthography (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 Italianlanguage (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
Exclusion Criteria:
- Intellectual disability
- Attention Deficit with Hyperactivity (ADHD)
- Neurological disorders
- Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearingaids.
- 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-controletc.) or with supplements who have not reached a stable administration schedule.
Study Design
Total Participants: 125
Treatment Group(s): 3
Primary Treatment: Neuropsychological intervention
Phase:
Study Start date:
May 02, 2020
Estimated Completion Date:
February 28, 2025
Connect with a study center
IRCCS "E. Medea" - La Nostra Famiglia
Bosisio Parini, (lc) 23842
ItalyActive - Recruiting
IRCCS E.Medea, polo di Conegliano
Conegliano, TV
ItalyActive - Recruiting
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