utritional deficiencies in children with Attention Deficit/Hyperactivity Disorder: A focus on amino acids
- Conditions
- Attention-deficit/hyperactivity disorderADHD10009841
- Registration Number
- NL-OMON39106
- Lead Sponsor
- Ansynth Service B.V.
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 187
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.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameters are the intake, absorption and excretion of the<br /><br>AAA*s tryptophan, tyrosine, phenylalanine and homocysteine, as measured by a<br /><br>food intake analysis (intake), a plasma analysis (absorption) and a urine<br /><br>analysis (excretion). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters, required to investigate the effects of the<br /><br>levels of the amino acids, are behavioural symptoms of ADHD (ADHD core symptoms<br /><br>and comorbid symptoms), neurocognitive, social-emotional and academic<br /><br>functioning and anthropometric measures. </p><br>