Attention-deficit/hyperactivity disorder
Conditions
Interventions
Children are treated with both (1) six weeks of nicotinamide supplementation
(an oral dose of 30 mg/kg/day, divided in six equally sized dosages), and (2)
six weeks of placebo (an oral dose of 30 mg
Sponsors
Ansynth Service B.V.
Eligibility
Age
2 Years to 17 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are the intake, absorption and excretion of the AAA*s tryptophan, tyrosine, phenylalanine and homocysteine, as measured by a food intake analysis (intake), a plasma analysis (absorption) and a urine analysis (excretion). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters, required to investigate the effects of the levels of the amino acids, are behavioural symptoms of ADHD (ADHD core symptoms and comorbid symptoms), neurocognitive, social-emotional and academic functioning and anthropometric measures. | — |
Countries
Netherlands
Outcome results
None listed