A randomised, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder
ISRCTN | ISRCTN47247160 |
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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
Scientific
Landluststraat 15
Middelburg
4337 KA
Netherlands
janckarman@planet.nl |
Study information
Study design | Prospective randomised, active controlled, parallel group treatment, efficacy, monocentric trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/08/2005 |
Completion date | 01/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 3 Years |
Upper age limit | 8 Years |
Sex | Not Specified |
Target number of participants | 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
4337 KA
Netherlands
Sponsor information
Child Psychiatry Department of Radboud University Nijmegen (The Netherlands)
University/education
University/education
c/o Prof. J.K. Buitelaar
Child and adolescent psychiatrist
Reinier Postlaan 10
Nijmegen
6500 HB
Netherlands
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/09/2010 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference and total final enrolment added.