Poly-unsaturated Fatty Acids and Developmental Dyslexia

NCT ID: NCT04287530

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-02
• Study Completion Date: 2025-02-28

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 tissue metabolism. Fatty acids carbon chains can be saturated (with no presence of double bonds) or unsaturated (with one or more double bonds). PUFAs fall into the unsaturated group, and they can be divided into two classes: omega-3 (n-3) and omega-6 (n-6) fatty acids (FAs). PUFAs are relevant components of cellular membranes, phospholipids, and precursors of eicosanoids, which influence neuronal development and functioning, docosahexaenoic acid (DHA) and arachidonic acid (AA) in fact are involved in cell growth, neural signaling, and gene expression. The main natural dietary source for Eicosapentaenoic acid (EPA) and DHA is fish oil. It has also been shown how the Magnocellular system, which includes the retinal ganglion cells, the lateral geniculate nucleus (for the visual system, while the medial geniculate nucleus would be involved for the auditory system) of the thalamus, the posterior parietal cortex, various areas visual of the cortex and part of the cerebellum, is sensitive to the contribution of fatty acids through nutrition. A deficit related to the Magnocellular system, specialized in the processing of stimuli with high temporal frequencies and low spatial frequencies, in both the visual and auditory modalities, has been proposed as one of the causes of Developmental Dyslexia (DD). According to this hypothesis, an alteration at the magnocellular level would affect reading by hampering temporal processing of the visual signal and would reduce the quality of the phonological representations due to imperfect acoustic analysis of the incoming phonemes. It is therefore possible to hypothesize that supplementation of PUFA in dyslexic children would improve the functions of the M-system and thus create better conditions to the remediation of reading difficulties, especially through remediation programs specifically tapping visual attention and rapid processing of visual stimuli. The remediation program currently used at Scientific Institute (IRCCS) Medea, "Tachidino", based on tachistoscopic, hemisphere-specific stimulation and on training of selective visual-spatial attention, has exactly these characteristics.

Hence, the present study aims to test the efficacy of PUFA supplementation before and during treatment with Tachidino.

Conditions

Dyslexia, Developmental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tachidino + PUFA supplementation

Group 1 will be treated with the usual rehabilitation protocol adopted at IRCCS E. Medea (remote intervention delivered through the Tachidino platform). The program will be delivered during four weeks, starting two months after the pre-testing session. Additionally, the children will receive daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Group Type: EXPERIMENTAL

Poly-unsaturated fatty acids supplementation

Intervention Type: DIETARY_SUPPLEMENT

Daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Neuropsychological intervention

Intervention Type: BEHAVIORAL

Rehabilitation protocol adopted at IRCCS "E. Medea" (remote intervention delivered through the Tachidino platform), delivered during four weeks, starting two months after the pre-testing session.

Tachidino + Placebo

Group 2 will be treated with the usual rehabilitation protocol adopted at IRCCS E. Medea (remote intervention delivered through the Tachidino platform), delivered during four weeks, starting two months after the pre-testing session, exactly as Group 1. Additionally, the children will receive daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Group Type: ACTIVE_COMPARATOR

Neuropsychological intervention

Intervention Type: BEHAVIORAL

Rehabilitation protocol adopted at IRCCS "E. Medea" (remote intervention delivered through the Tachidino platform), delivered during four weeks, starting two months after the pre-testing session.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

PUFA supplementation

Groups 3 will receive only daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Group Type: EXPERIMENTAL

Poly-unsaturated fatty acids supplementation

Intervention Type: DIETARY_SUPPLEMENT

Daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Placebo

Groups 4 will receive only daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Control group

Typically Developing participants, as a comparison group for experimental tasks and for PUFA levels in the blood

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Poly-unsaturated fatty acids supplementation

Daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Intervention Type: DIETARY_SUPPLEMENT

Neuropsychological intervention

Rehabilitation protocol adopted at IRCCS "E. Medea" (remote intervention delivered through the Tachidino platform), delivered during four weeks, starting two months after the pre-testing session.

Intervention Type: BEHAVIORAL

Placebo

Daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Equazen Eye Q chewable capsules; Tachidino; Equazen Eye Q red Placebo chewable capsules

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Milan

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: collaborator

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Luisa Lorusso, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Eugenio Medea

Locations

IRCCS "E. Medea" - La Nostra Famiglia

Bosisio Parini, (LC), Italy

Site Status: RECRUITING

IRCCS E.Medea, polo di Conegliano

Conegliano, TV, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Luisa Lorusso, PhD

Role: CONTACT

marialuisa.lorusso@lanostrafamiglia.it

031877919 ext. 0039

Francesca Borasio, PhD

Role: CONTACT

francesca.borasio@lanostrafamiglia.it

031877919 ext. 0039

Facility Contacts

Maria Luisa Lorusso, PhD

Role: primary

marialuisa.lorusso@lanostrafamiglia.it

031877919 ext. 0039

Francesca Borasio, PhD

Role: backup

francesca.borasio@lanostrafamiglia.it

031877919 ext. Lorusso

Federica Martinez, MD

Role: primary

federica.martinez@lanostrafamiglia.it

References

Borasio F, Syren ML, Turolo S, Agostoni C, Molteni M, Antonietti A, Lorusso ML. Direct and Indirect Effects of Blood Levels of Omega-3 and Omega-6 Fatty Acids on Reading and Writing (Dis)Abilities. Brain Sci. 2022 Jan 27;12(2):169. doi: 10.3390/brainsci12020169.

Reference Type: BACKGROUND

PMID: 35203933 (View on PubMed)

Borasio F, De Cosmi V, D'Oria V, Scaglioni S, Syren ME, Turolo S, Agostoni C, Coniglio M, Molteni M, Antonietti A, Lorusso ML. Associations between Dietary Intake, Blood Levels of Omega-3 and Omega-6 Fatty Acids and Reading Abilities in Children. Biomolecules. 2023 Feb 15;13(2):368. doi: 10.3390/biom13020368.

Reference Type: BACKGROUND

PMID: 36830737 (View on PubMed)

Other Identifiers

677

Identifier Type: -

Identifier Source: org_study_id