1. Randomised controlled determination of the influence of foods on the behaviour of a heterogeneous not-selected group primary school children, during the first two months of the trial. 2. Determination of an IgG or IgE-mediated respons to foods,…
ID
Source
Brief title
Condition
- Allergic conditions
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parent and teacher ratings on the Short Conners List and the ADHD Rating Scale,
with three important measure points: At the start of the trial, after a
baselineperiod, and at the end of the diet or waiting list period.
Secondary outcome
The levels of IgE and IgG before and after the diet, comorbid problems like ODD
and physical complaints, comparing the controlgroup with the dietgroup and each
child with itself.
Background summary
ADHD is a higly hereditable disorder, our knowledge of the mechanism leading to
ADHD are speculative however, thus restricting the prospects of prevention.
Some environmental influences may play a role in the manifestation of the
disorder. One of these factors may be nutrition. Previous research into the
influence of foods on ADHD showed convincing double-blind controlled evidence,
but further research was advised to define the target subgroup, these studies
mostly concerning selected groups of children. Therefore the subjects in this
study will be an aselect, group, not selected on affinity with dietary
interventions. The hypothesis is tested that the results of previous research
are also applicable to a heterogeneous group of children suffering from ADHD.
It might be conceivable that immunological mechanisms, by means of IgG- or
IgE-antibodies, play a role in children with ADHD being sensible to foods. To
examine this possibility, bloodtests will be done before and after following an
elimination diet, to determain the IgE levels and the IgG-levels of at least
250 different foods. The hypothesis will be tested that, in children showing a
significant decrease in symptoms after following the elimination diet, foods
with low IgG-levels are not a causal factor of ADHD. Finally the hypothesis is
tested that 75% of the subjects are capable to keep to a diet.
Study objective
1. Randomised controlled determination of the influence of foods on the
behaviour of a heterogeneous not-selected group primary school children,
during the first two months of the trial. 2. Determination of an IgG or
IgE-mediated respons to foods, to investigate whether bloodtests in children
with ADHD may contribute to dietary intervention, in the third month of the
trial. 3. Investigation of the long-term effect of a diet on ADHD, during month
4-12 of the trial.
Study design
100 children, the ADHD diagnosis being confirmed by a paediatrician, will be
randomly assigned to either a diet group or a control group. The trial can be
divided in two phases, in the first phase the efficacy of an elimination diet
will be investigated, in the second phase will be determined which foods are
involved. During the first phase, after a baselineperiod for the dietgroup as
well as the controlgroup, the dietgroup will follow an elimination diet, whilst
the control group will be placed on a waiting list and adhere to their normal
food pattern. Only children showing significant improvement in behaviour
(responders) will enter the second phase, the provocation phase. The first
phase and the first 4 weeks of the second phase is a randomised controlled
trial (week 1-13), being followed by an open trial (week 14-52). Blood tests
will be executed at the start of the trial (week 0), after the diet phase (week
9) and at the end of the RCT (week 13). The four most important measure points
are in week 0, 9, 13, 52.
Intervention
Children have to stick to an elimination diet for 5 weeks, the responders
(improvement of behaviour of at least 40%) going on with an individually
assessed provocation diet, based on the IgG-bloodtests in week 0. The control
group is placed on a waiting list, but are offered to start with the
elimination diet after the last RCT measure point (week 13).
Study burden and risks
The most important burden is the adherence to a different diet than the
children are used to. Previous studies showed that this, according to the
parents, is not a big problem. The diet has to be followed for only five weeks,
which is not too long. After the diet children are allowed to eat everything
again (nonresponders), or the diet will be expanded (responders) The obtaining
of the blood samples may be a burden to the children, but a present to be
choosed will probably solve this problem. The children will be investigated by
a paediatrician once. There are no extra risks involved associated with
participation.
Marijkeweg 40
6706 PG Wageningen
Nederland
Marijkeweg 40
6706 PG Wageningen
Nederland
Listed location countries
Age
Inclusion criteria
Diagnosis ADHD,according to the DSM-IV, combined or hyperactive/impulsive subtype.
Age 4-8.
No medication to improve the behaviour, e.g. methylphenidate, is prescribed.
The behaviour problems started before reaching the age of four.
Willing to go through bloodtests three times.
Exclusion criteria
Family conditions, impeding the compliance to the diet.
The child has had or has lately been following an elimination diet.
The child is already engaged in a therapeutic treatment for the behaviour problems.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12736.081.06 |