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Clinical Trials/NL-OMON39106
NL-OMON39106
Completed
N/A

utritional deficiencies in children with Attention Deficit/Hyperactivity Disorder: A focus on amino acids - Nutrients and ADHD.

Ansynth Service B.V.0 sites187 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention-deficit/hyperactivity disorder
Sponsor
Ansynth Service B.V.
Enrollment
187
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
July 3, 2014
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Ansynth Service B.V.

Eligibility Criteria

Inclusion Criteria

  • For both groups (the clinical group that consists of children with ADHD and the reference group) the inclusion criteria are that children are (a) between 6 and 13 years old and (b) in grade 1 to 6 from elementary school. Children in the clinical group have received a clinical diagnosis of ADHD, confirmed by standardized assessments.

Exclusion Criteria

  • There is one exclusion criterion for the clinical group and that is that children will not be able to participate when they use methylphenidate (MPH) during the testing. The behaviour and functioning of children should not be influenced by medication when they will be assessed. Children who are receiving a psychopharmacological treatment for ADHD could discontinue their treatment for a short period in order to be able to participate. After the discontinuation of stimulant use, a complete washout will be achieved within 48 hours (Pelham et al., 1999\). Therefore, the medication break could be limited to five days (two days before the testing period and three days of testing). Stimulant medication is often discontinued (initiated by parents) during weekends or school\-holidays in order to limit the consequences of the negative side effects associated with the use of MPH. The decision for a medication break of five days will be taken in consultation with the responsible psychiatrist of the child.
  • There will be no exclusion criteria for comorbid disorders that frequently co\-occur with ADHD, such as oppositional defiant disorder (ODD), conduct disorder (CD), autism spectrum disorder (ASD) or learning disorders. Using these exclusion criteria would decrease the probability of having a representative sample.

Outcomes

Primary Outcomes

Not specified

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