This double blind, randomised controlled trial examines the effect of a commercially available nutritional supplement on behaviour of ADHD patients, as well as on their physical and psychiatric co-morbidities, and level of oxidative stress and immune activity, as compared to placebo and standard pharmaceutical treatment for ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks.
Standard pharmaceutical treatment for ADHD, slow release.
Placebo treatment (identical capsules containing excipients only)
Universitaire Kinder- en Jeugdpsychiatrie
Borgerhout, Belgium
University Hospital Antwerp
Edegem, Belgium
University Hospital Ghent
Ghent, Belgium
Summed ADHD score of the ADHD-Rating Scale as rated by teachers
Time frame: 10 weeks
Summed ADHD score of the ADHD-Rating Scale as rated by teachers
Time frame: 5 weeks
Summed ADHD score of the ADHD-Rating Scale as rated by parents
Time frame: 5 weeks, 10 weeks
Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents and teachers
Time frame: 10 weeks
Scores on ADHD subscales of the ADHD-RS as rated by parents and teachers - hyperactivity, impulsivity and inattention
Time frame: 5 & 10 weeks
Scores on ADHD subscales of the SEQ as rated by parents and teachers - hyperactivity, impulsivity and inattention
Time frame: 5 & 10 weeks
Percentage of responders (ADHD-RS) as rated by parents and teachers
Score reduction of at least 20% for parents and/or teachers
Time frame: 5 & 10 weeks
Percentage of responders (SEQ) as rated by parents and teachers
Score reduction of at least 20% for parents and/or teachers
Time frame: 5 & 10 weeks
Social behavior problems subscale of the SEQ, as rated by parents and teachers
Time frame: 10 weeks
Anxiety subscale of the SEQ, as rated by parents and teachers
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Time frame: 10 weeks
Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ)
Time frame: 5 & 10 weeks
Erythrocyte glutathione (GSH) level
Time frame: 10 weeks
Urinary 8-OHdG level
Time frame: 10 weeks
Plasma cytokine levels
Time frame: 10 weeks
Plasma antibody levels
Time frame: 10 weeks
Gene expression
Time frame: 10 weeks
Serum neuropeptide Y
Time frame: 10 weeks
Serum zinc
Time frame: 10 weeks
Intestinal microbial composition
Time frame: 10 weeks
Intervention acceptability
Percentage of participants with side effects, treatment adherence and proportion of drop-outs
Time frame: 10 weeks
Intervention acceptability
Percentage of participants with side effects
Time frame: 10 weeks
Intervention acceptability
Proportion of drop-outs
Time frame: 10 weeks
Intervention acceptability
Treatment adherence
Time frame: 10 weeks
Urinary catecholamines
Time frame: 10 weeks
Plasma lipid-soluble vitamins
Time frame: 10 weeks
Long-term follow up
Long-term follow up on eventual treatment choice (medication, no intervention, nutritional supplement)
Time frame: 6 months
Long-term follow up
Long-term follow up on behaviour
Time frame: 6 months
Long-term follow up
Long-term follow up on physical/psychiatric complaints
Time frame: 6 months