Effects of Poly-unsaturated Fatty Acids on Developmental Dyslexia
Poly-unsaturated Fatty Acids and Developmental Dyslexia: Correlations With Cognitive Performance and Effects of Supplementation in Addition to Neuropsychological Treatment
This study is testing if giving children with developmental dyslexia a supplement of poly-unsaturated fatty acids can help improve their reading skills compared to a placebo and a neuropsychological intervention.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 7 Years to 15 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 2 sites (Bosisio Parini, (lc) and 1 other locations) |
| Trial ID | NCT04287530 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of poly-unsaturated fatty acids (PUFAs) on children diagnosed with developmental dyslexia. Participants aged 7 to 15 will receive either PUFA supplementation, a neuropsychological intervention, or a placebo. The study aims to assess the role of PUFAs in neuronal development and functioning, particularly in relation to reading abilities. The research will include both dyslexic participants and a control group without reading difficulties to compare outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 15 with a formal diagnosis of developmental dyslexia and no prior specific rehabilitation treatment.
Not a fit: Patients who do not have a diagnosis of dyslexia or have received prior treatment for the condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new dietary interventions to improve reading skills in children with developmental dyslexia.
How similar studies have performed: While the role of PUFAs in cognitive function has been explored, this specific approach to treating developmental dyslexia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bosisio Parini, (lc) and 1 other locations
- IRCCS "E. Medea" - La Nostra Famiglia — Bosisio Parini, (lc), Italy (Recruiting)
- IRCCS E.Medea, polo di Conegliano — Conegliano, Tv, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Luisa Lorusso, PhD — IRCCS Eugenio Medea
- Study coordinator: Maria Luisa Lorusso, PhD
- Email: marialuisa.lorusso@lanostrafamiglia.it
- Phone: 031877919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.