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
Secondary identifying numbers N/A
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

Study designProspective randomised, active controlled, parallel group treatment, efficacy, monocentric trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA randomised, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder
Study objectivesThe 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) studiedAttention Deficit Hyperactivity Disorder (ADHD)
InterventionThe 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 typeOther
Primary outcome measureParent 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
Secondary outcome measures1. 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
Overall study start date01/08/2005
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit8 Years
SexNot Specified
Target number of participants80
Total final enrolment27
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2005
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Landluststraat 15
Middelburg
4337 KA
Netherlands

Sponsor information

Child Psychiatry Department of Radboud University Nijmegen (The Netherlands)
University/education

c/o Prof. J.K. Buitelaar
Child and adolescent psychiatrist
Reinier Postlaan 10
Nijmegen
6500 HB
Netherlands

ROR logo "ROR" https://ror.org/05wg1m734

Funders

Funder type

Charity

Foundation for Children's Welfare Stamps Netherlands (The Netherlands)

No information available

Foundation Nuts Ohra (The Netherlands)

No information available

Matty Brand Foundation (The Netherlands)

No information available

Foundation of Child and Behaviour (Stichting Kind en Gedrag) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.