Status:
COMPLETED
Biomarker Research in ADHD: the Impact of Nutrition
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
ADHD Research Centre
Conditions:
Attention Deficit-Hyperactivity Disorder
Eligibility:
MALE
8-10 years
Phase:
NA
Brief Summary
Attention deficit hyperactivity disorder (ADHD) is the most common childhood behavioural disorder, causing significant impediment to a child's development. The exact aetiology of ADHD is still unknown...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03440346
Start Date
February 19 2018
End Date
June 21 2019
Last Update
July 1 2019
Active Locations (1)
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1
Wageningen University
Wageningen, Netherlands