Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03440346 : Biomarker Research in ADHD: the Impact of Nutrition
PhaseN/A
AgesMin: 8 Years Max: 10 Years
Eligibility
Inclusion Criteria:

- Meeting DSM-IV ADHD criteria

- Male

- Aged 8 up to and including 10 years

- Right-handed

- Available to visit Wageningen University for 4 sessions (i.e. intake, screening, T1
and T2), of which 3 sessions including the child (screening, T1, T2)

- Upon study start, fully understanding and agreeing to the study objectives and having
dated and signed an informed consent to participate in the study, including permission
that material will be used or archived for (epi)genetic testing

- Willing to be informed about chance-findings that may have implications for the health
of the child or his family, and approving of reporting this to the child's medical
specialist or family's general physician.

- If the child uses "over the counter" medication, e.g. laxatives, melatonin for
sleeping problems or hay fever medication, parents are asked to share the information
leaflet, and if necessary participants are asked to change to alternatives that are
free of additives that may affect ADHD, e.g. laxatives free of artificial sweeteners,
sugar and cacao.

Exclusion Criteria:

- Diagnosis Autism Spectrum Disorder

- Diagnosis Developmental Coordination Disorder

- Premature birth (< 36 weeks) and/or oxygen deprivation during birth

- Diagnosed chronic gastrointestinal disorder, i.e. inflammatory bowel disease,
irritable bowel syndrome, celiac disease, non-celiac gluten-intolerance
(gluten-sensitivity) or lactose-intolerance

- Auto-immune disorder (e.g. diabetes mellitus type 1)

- Vegetarian/vegan

- Diagnosis dyslexia and/or dyscalculia

- IQ < 85

- Following behavioural therapy

- Use of ADHD medication

- Use of systemic antibiotics, antifungals, antivirals or antiparasitics in the past six
months

- Insufficient command of the Dutch language by either parents or child that may affect
understanding and execution of study and dietary instructions

- Family circumstances that may compromise following or completion of the diet,
including but not limited to family relational problems

- Having a contra-indication to MRI scanning (including, but not limited to): pacemakers
and defibrillators, intraorbital or intraocular metallic fragments, ferromagnetic
implants, claustrophobia.

- Two weeks prior to the start of the study, dietary supplements (e.g. antioxidants,
minerals, vitamins) or pro- or prebiotics use has to be stopped.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03440346      |      Link to official Clinicaltrials.gov listing
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