Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
29/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr J Karman

ORCID ID

Contact details

Landluststraat 15
Middelburg
4337 KA
Netherlands
janckarman@planet.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Prospective randomised, active controlled, parallel group treatment, efficacy, monocentric trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/08/2005

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

80

Participant 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)

Recruitment start date

01/08/2005

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Landluststraat 15
Middelburg
4337 KA
Netherlands

Sponsor information

Organisation

Child Psychiatry Department of Radboud University Nijmegen (The Netherlands)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation Nuts Ohra (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Matty Brand Foundation (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes