Dyslexia, DevelopmentalNCT04287530
Poly-unsaturated Fatty Acids and Developmental Dyslexia
A study testing Poly-unsaturated fatty acids supplementation and Neuropsychological intervention in people with Dyslexia, Developmental, run by IRCCS Eugenio Medea at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia, Developmental
- What is being tested?
- Poly-unsaturated fatty acids supplementation and Neuropsychological intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 2 sitesItaly
- Study dates
- 2 May 2020to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Show all 13Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS "E. Medea" - La Nostra Famiglia
Bosisio Parini, (LC), 23842
Maria Luisa Lorusso, PhD, 031877919 ext. 0039, marialuisa.lorusso@lanostrafamiglia.it
Francesca Borasio, PhD, 031877919 ext. Lorusso, francesca.borasio@lanostrafamiglia.it
- Recruiting
IRCCS E.Medea, polo di Conegliano
Conegliano, TV
Federica Martinez, MD, federica.martinez@lanostrafamiglia.it
Federica Martinez, MD
About this study
Official title: Poly-unsaturated Fatty Acids and Developmental Dyslexia: Correlations With Cognitive Performance and Effects of Supplementation in Addition to Neuropsychological Treatment
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
- Being tested
- Poly-unsaturated fatty acids supplementation, Neuropsychological intervention, Placebo
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-unsaturated fatty acids supplementationDietary supplement
Also called Equazen Eye Q chewable capsules
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 interventionBehavioural
Also called Tachidino
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.
PlaceboDietary supplement
Also called Equazen Eye Q red Placebo chewable capsules
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.
| Study group | Role | What they receive |
|---|---|---|
| Tachidino + PUFA supplementation | Experimental | 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. Receives: Dietary Supplement: Poly-unsaturated fatty acids supplementation; Behavioral: Neuropsychological intervention |
| Tachidino + Placebo | Active comparator | 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. Receives: Behavioral: Neuropsychological intervention; Dietary Supplement: Placebo |
| PUFA supplementation | Experimental | 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. Receives: Dietary Supplement: Poly-unsaturated fatty acids supplementation |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
| Control group | No intervention | Typically Developing participants, as a comparison group for experimental tasks and for PUFA levels in the blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
PUFA supplementation effects on the results of neuropsychological intervention
Difference in treatment-related changes (post-test minus pre-test) observed in reading measures (speed and accuracy in word, nonword and text reading; average of the scores expressed as z-scores with respect to age norms) between the experimental group (Tachidino + PUFA supplementation) and the comparison group (Tachidino + placebo)
Measured: 3 months
Secondary outcomes (7)
Changes in Rapid Automatized Naming (RAN) due to supplementation with PUFAs
Difference in change-scores (i.e. post-test minus pre-test) observed in Rapid Automatized Naming (z-scores with respect to age norms) in the experimental group versus placebo
Measured: 3 months
Changes in visual search functions due to supplementation with PUFAs
Difference in change-scores (i.e. post-test minus pre-test) observed in Visual Search scores (z-scores with respect to age norms) in the experimental group versus placebo
Measured: 3 months
Changes in Magnocellular functions due to supplementation with PUFAs
Difference in change-scores (i.e. post-test minus pre.test scores) observed in neuropsychological measures related to Magnocellular functions (Magnocellular tasks in the visual modality, efficiency expressed in msec) in the experimental group versus placebo
Measured: 3 months
Correlations between blood levels of PUFA and reading performance
Pearson's correlation index between PUFA levels in the blood (Ratio omega-6/omega-3) and reading performance expressed in z-scores
Measured: Baseline
Correlations between blood levels of PUFA and writing performance
Pearson's correlation index between PUFA levels in the blood (Ratio omega-6/omega-3) and writing performance expressed in z-scores
Measured: Baseline
Change in blood levels of PUFAs in children with Dyslexia
Changes (post-test versus pre-test levels) in blood levels of PUFAs (Ratio omega-6/omega-3) for children with DD after 3 months supplementation
Measured: 3 months
Changes in blood levels of PUFAs relate to changes in reading performance in children with Dyslexia
Pearson's correlation index between changes in PUFA levels (i.e. post-test minus pre-test levels) in the blood (Ratio omega-6/omega-3) and change-scores (i.e. post-test minus pre-test scores) in reading performance in children with DD (expressed in z-scores)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start2 May 2020
- Primary completionOct 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dyslexia, DevelopmentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Responsible party
- Sponsor
- Investigators
- Maria Luisa Lorusso, PhD, Principal investigator, IRCCS Eugenio Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287530
- Sponsor's protocol ID
- 677
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35203933Borasio 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.
PubMed 36830737
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poly-unsaturated Fatty Acids and Developmental Dyslexia: Correlations With Cognitive Performance and Effects of Supplementation in Addition to Neuropsychological Treatment
- ClinicalTrials.gov ID
- NCT04287530
- Acronym / sponsor ID
- 677
- Conditions
- Dyslexia, Developmental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 2 May 2020 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tachidino + PUFA supplementation | Experimental | Dietary Supplement: Poly-unsaturated fatty acids supplementation, Behavioral: Neuropsychological interventionGroup 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. |
| Tachidino + Placebo | Active comparator | Behavioral: Neuropsychological intervention, Dietary Supplement: PlaceboGroup 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. |
| PUFA supplementation | Experimental | Dietary Supplement: Poly-unsaturated fatty acids supplementationGroups 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboGroups 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. |
| Control group | No intervention | –Typically Developing participants, as a comparison group for experimental tasks and for PUFA levels in the blood |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-unsaturated fatty acids supplementationAlso: Equazen Eye Q chewable capsulesDaily 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. | Dietary supplement | PUFA supplementation, Tachidino + PUFA supplementation |
| Neuropsychological interventionAlso: TachidinoRehabilitation 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. | Behavioural | Tachidino + PUFA supplementation, Tachidino + Placebo |
| PlaceboAlso: Equazen Eye Q red Placebo chewable capsulesDaily 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. | Dietary supplement | Placebo, Tachidino + Placebo |
Primary outcome
PUFA supplementation effects on the results of neuropsychological intervention
Time frame: 3 months
Difference in treatment-related changes (post-test minus pre-test) observed in reading measures (speed and accuracy in word, nonword and text reading; average of the scores expressed as z-scores with respect to age norms) between the experimental group (Tachidino + PUFA supplementation) and the comparison group (Tachidino + placebo)
7 secondary outcomes
Changes in Rapid Automatized Naming (RAN) due to supplementation with PUFAs
Time frame: 3 months
Changes in visual search functions due to supplementation with PUFAs
Time frame: 3 months
Changes in Magnocellular functions due to supplementation with PUFAs
Time frame: 3 months
Correlations between blood levels of PUFA and reading performance
Time frame: Baseline
Correlations between blood levels of PUFA and writing performance
Time frame: Baseline
Change in blood levels of PUFAs in children with Dyslexia
Time frame: 3 months
Changes in blood levels of PUFAs relate to changes in reading performance in children with Dyslexia
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 35203933Borasio 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.
- Background: PubMed 36830737Borasio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luisa Lorusso, PhD principal investigator
IRCCS Eugenio Medea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-unsaturated fatty acids supplementation and Neuropsychological intervention in people with Dyslexia, Developmental, run by IRCCS Eugenio Medea at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Luisa Lorusso, PhD (031877919 ext. 0039, marialuisa.lorusso@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PUFA supplementation effects on the results of neuropsychological intervention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04287530, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.