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
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