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A randomized, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder (ADHD).

A randomized, controlled study into the effects of food on the behaviour of young children with attention-deficit hyperactivity disorder (ADHD).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26249
Enrollment
80
Registered
2005-09-01
Start date
2007-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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
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. Followin

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. ADHD combined subtypes or hyperactive/impulsive subtypes diagnosed according to DSM IV; diagnoses based on structured psychiatric interviews and standard questionnaires (10-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.

Exclusion criteria

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. 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 PDD, PDD-NOS and/or MCDD.

Design outcomes

Primary

MeasureTime frame
Parent and teacher ratings on the 10-item Conners list and the ADHD rating scale. There are three measurement points: (i) the start of the trial; (ii) the end of the baseline period, and (iii) the end of the diet or control period.

Secondary

MeasureTime frame
Parent ratings on oppositional defiant behaviour, aggressive behaviour, compulsive behaviour, nervous tremors or obsessive behaviour. 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.

Contacts

Public ContactJ. Karman

Stichting Kind en Gedrag, Landluststraat 15

janckarman@planet.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)