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A randomized, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder (ADHD).


- candidate number0
- NTR NumberNTR242
- ISRCTNISRCTN47247160
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR1-sep-2005
- Secondary IDsN/A 
- Public TitleA randomized, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder (ADHD).
- Scientific TitleA randomized, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder (ADHD).
- ACRONYMN/A
- hypothesisThe effects of foods on children with ADHD will be determined in a randomized, controlled trial. Can the results of earlier open-diet trials in the Netherland, 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.
- Healt Condition(s) or Problem(s) studiedAttention Deficit Hyperactivity Disorder (ADHD), Oppositional defiant disorder (ODD)
- Inclusion criteria1. ADHD combined subtypes or hyperactive/impulsive subtypes diagnosed according to DSM IV; diagnoses based on structured psychiatric interviews and standard questionnaires (10-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.
- Exclusion criteria1. Adopted children and foster children; 2. Children taking and responding to medication; 3. Co-existing neurological diseases, such as epilepsy, neurofibromatosis, etc.; 4. 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 PDD, PDD-NOS and/or MCDD.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mei-2007
- planned closingdate1-mei-2010
- Target number of participants80
- InterventionsThe 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 4-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.
- Primary outcomeParent and teacher ratings on the 10-item Conners list and the ADHD rating scale. There are three measurement points: (i) the start of the trial; (ii) the end of the baseline period, and (iii) the end of the diet or control period.
- Secondary outcomeParent ratings on oppositional defiant behaviour, aggressive behaviour, compulsive behaviour, nervous tremors or obsessive behaviour. 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.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Karman
- CONTACT for SCIENTIFIC QUERIES L.M.J. Pelsser
- Sponsor/Initiator University Medical Center St. Radboud, Department of Child Psychiatry, Research Centre for ADHD and Nutrition
- Funding
(Source(s) of Monetary or Material Support)
The Foundation for Children’s Welfare Stamps Netherlands (Stichting Kinderpostzegels Nederland, SKN), Stichting Nuts Ohra, Matty Brand Stichting, Foundation of Child and Behaviour (Stichting Kind en Gedrag)
- PublicationsN/A
- Brief summary80 children, 3-8 years old, are randomly assigned to either a diet group or a control group. After a two weeks-baseline period, 40 children 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 and will be completed by parents and teachers at the start of the trial, after the baseline period and after the diet- or controlperiod. Following the final measurement, families in the control group may also choose to start the food elimination diet.
- Main changes (audit trail)
- RECORD20-sep-2005 - 20-dec-2006


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