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ISRCTN
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ISRCTN47247160
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ClinicalTrials.gov identifier
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Public title
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A randomised, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The effects of foods on children with Attention-Deficit Hyperactivity Disorder (ADHD) will be determined in a randomised, controlled trial. Can the results of earlier open-diet trials in The Netherlands (i.e., 60% of the participants showed an improvement in behaviour of 50% or more) be confirmed?
The prediction tested is that a few foods diet wil lead to a significant improvement of behaviour in children with ADHD.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Prospective randomised, active controlled, parallel group treatment, efficacy, monocentric trial.
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Attention Deficit Hyperactivity Disorder (ADHD)
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Participants - inclusion criteria
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1. ADHD combined subtypes or hyperactive/impulsive subtypes diagnosed according to Diagnostic and Statistical Manual of mental disorders fourth edition (DSM IV); diagnoses based on structured psychiatric interviews and standard questionnaires (ten-item Conners list and ADHD rating scale) to be completed by parents and teachers
2. Children aged between three and eight
3. Children not taking or not responding adequately to medication
4. Behavioural problems originating prior to children reaching the age of four
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Participants - exclusion criteria
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1. Adopted children and foster children
2. Children taking and responding to medication
3. Co-existing neurological diseases, such as epilepsy, neurofibromatosis, etc..,
4. Intelligence Quotient (IQ) below 70
5. Alcohol/drugs use or smoking by mother during pregnancy
6. Prematurity/dysmaturity (children born before 36th week of pregnancy or with a weight below 1500 grams) or problems during delivery requiring admission to the neonatal intensive care unit
7. Children diagnosed Pervasive Developmental Disorder (PDD), Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and/or Multiple-Complex Developmental Disorder (MCDD)
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Anticipated start date
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01/08/2005
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Anticipated end date
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01/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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80
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Interventions
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The children are assigned at random to either a diet group or a control group. Each group consists of 40 children. Following the baseline period, the children placed in the diet group will follow a four-week food elimination diet, whilst the children assigned to the control group will be placed on a waiting list; they will adhere to their normal food pattern. Children in the control group are not offered any other treatment. Identical questionnaires and measurement times are used for the two groups. Following the final measurement, families in the control group may also choose to start the food elimination diet.
Scientific contact: Ms. L.M.J. Pelsser, lmjpelsser@worldmail.nl
Please note that the anticipated start and end dates of this trial have changed to 1st May 2007 and 1st May 2010 respectively.
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Primary outcome measure(s)
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Parent and teacher ratings on the 10-item Conners list and the ADHD rating scale. There are three measurement points:
1. The start of the trial
2. The end of the baseline period, and
3. The end of the diet or control period
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Secondary outcome measure(s)
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1. Parent ratings on oppositional defiant behaviour, aggressive behaviour, compulsive behaviour, nervous tremors or obsessive behaviour
2. Parents ratings on other complaints the child may experience. Questions are asked about physical complaints, such as gastrointestinal problems, headaches, stomach aches, eczema, asthma, ear, nose or throat complaints, nosebleeds, excessive sweating, and sleeping problems
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Sources of funding
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1. Foundation for Children's Welfare Stamps Netherlands (The Netherlands)
2. Foundation Nuts Ohra (The Netherlands)
3. Matty Brand Foundation (The Netherlands)
4. Foundation of Child and Behaviour (Stichting Kind en Gedrag) (The Netherlands)
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Trial website
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Publications
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Contact name
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Mr
J
Karman
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Address
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Landluststraat 15
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City/town
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Middelburg
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Zip/Postcode
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4337 KA
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Country
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Netherlands
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Email
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janckarman@planet.nl
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Sponsor
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Child Psychiatry Department of Radboud University Nijmegen (The Netherlands)
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Address
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c/o Prof. J.K. Buitelaar
Child and adolescent psychiatrist
Reinier Postlaan 10
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City/town
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Nijmegen
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Zip/Postcode
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6500 HB
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Country
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Netherlands
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Date applied
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20/12/2005
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Last edited
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29/03/2007
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Date ISRCTN assigned
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20/12/2005
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