The objective of this pilot study is testing whether the supplementation of vitamins and minerals can reduce aggressive behavior and improve quality of life in people with mild intellectual disability. With sufficient results a follow-up research is…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Agressief gedrag
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The reduction of aggressive behavior. .Aggression is measured on the basis of a
daily score on the Modified Overt Aggression Scale (MOAS).
Secondary outcome
The effect of the supplements on the quality of life. It is also examined
whether the effect of nutritional supplements on aggressive behavior is
mediated by positive and negative affect. The positive and negative affect is
measured daily, using two items derived from the abbreviated Positive And
Negative Affect Schedule (PANAS). The Reactive and Proactive Aggression Scale
(RePro) is used to distinguish between reactive and proactive aggression. The
Intellectual Disability Quality of Life scale is used (IDQOL-16) for measuring
the quality of life. The effects are controlled for sex, age, medication,
sweets, alcohol consumption and tobacco consumption.
Background summary
Literature shows that most people with mild intellectual disability do not keep
an optimal diet and have a higher degree of alcohol, tobacco and medicine
consumption than the general population. In addition, they face a higher level
of stress. These factors can cause relative shortage of vitamins and minerals.
A relative shortage of vitamins and minerals may provide a sub-optimal
performance of a number of neurotransmitter systems, which may affect behavior.
Earlier research has shown that supplementation of vitamins and minerals can
help reduce aggressive behavior in certain target groups.
The research question of this study is: is supplementation of vitamins and
minerals effective in reducing aggressive behavior in a population consisting
of people with mild intellectual disabilities? The following assumptions are
made:
* supplementation of vitamins and minerals will lead to a lesser degree of
aggressive behavior in comparison with the placebo condition.
* The supplementation of vitamins and minerals will lead to a lower negative
affect and higher positive affect as compared to the placebo condition.
* There is a positive correlation between negative affect and reactive
aggression.
* The effect of nutritional supplements on aggression is partially mediated by
negative affect.
* Supplementation of vitamins and minerals will lead to a higher quality of
life compared with the placebo condition.
Study objective
The objective of this pilot study is testing whether the supplementation of
vitamins and minerals can reduce aggressive behavior and improve quality of
life in people with mild intellectual disability. With sufficient results a
follow-up research is possible, in order to develop a treatment for reducing
aggression in the social care.
Study design
The design is a randomised double-blind placebo controlled trial, studying the
effect of the supplementation of vitamins and minerals on aggressive behaviour
by people with a mild intellectual disability.
Intervention
The intervention group will receive daily a multivitamin and mineral tablet,
during a period of ten weeks. The placebo group will receive an identical
looking tablet containing starch. The baseline is measured in the week before
the intervention starts.
Study burden and risks
The burden for the participant consists of the daily intake of a tablet and the
communicating about their affect with their attendant. Further there are three
questionnaires to be filled in this will take about an hour.
Dr. Molewaterplein 50
Rotterdam 3015 GJ
NL
Dr. Molewaterplein 50
Rotterdam 3015 GJ
NL
Listed location countries
Age
Inclusion criteria
The pricipal inclusion criteria are: mild intellectual disability ( IQ 50-85) with behavior problems; age 18 till 40, minimum once a week aggressive behavior according to the reports of the care institution, ten week from the beginning of the intervention.
Exclusion criteria
Exclusion criteria are; users of multivitamin supplements, pregnancy, swallowing problems and users of medication with possible interactions with vitamins and minerals: digoxin, ACE-inhibitors methyldopa, sulfasalazin, levothyroxin, colestyramin, tetracycline antibiotics and warfarin.
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 | NL45255.078.13 |