A randomised, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder

ISRCTN	ISRCTN47247160
DOI	https://doi.org/10.1186/ISRCTN47247160
Protocol serial number	N/A
Sponsor	Child Psychiatry Department of Radboud University Nijmegen (The Netherlands)
Funders	Foundation for Children's Welfare Stamps Netherlands (The Netherlands), Foundation Nuts Ohra (The Netherlands), Matty Brand Foundation (The Netherlands), Foundation of Child and Behaviour (Stichting Kind en Gedrag) (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 07/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr J Karman
Scientific

Landluststraat 15
Middelburg
4337 KA
Netherlands

Email	janckarman@planet.nl

Study information

Primary study design	Interventional
Study design	Prospective randomised, active controlled, parallel group treatment, efficacy, monocentric trial.
Secondary study design	Randomised controlled trial
Scientific title	A randomised, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Attention Deficit Hyperactivity Disorder (ADHD)
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/12/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	8 Years
Sex	Not Specified
Target sample size at registration	80
Total final enrolment	27
Key inclusion criteria	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
Key exclusion criteria	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)
Date of first enrolment	01/08/2005
Date of final enrolment	01/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Landluststraat 15

Middelburg
4337 KA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2010	07/01/2021	Yes	No

Editorial Notes

07/01/2021: Publication reference and total final enrolment added.