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The Inca study: Impact of Nutrition on Children with ADHD. A randomised, controlled trial into the effects of a few foods diet on the behaviour of a heterogeneous, not selected group of primary school children, meeting the DSM-IV-criteria of ADHD

The Inca study: Impact of Nutrition on Children with ADHD. A randomised, controlled trial into the effects of a few foods diet on the behaviour of a heterogeneous, not selected group of primary school children, meeting the DSM-IV-criteria of ADHD - INCA study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30659
Enrollment
100
Registered
2007-11-20
Start date
2008-09-01
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

HKS (Hyperkinetic Syndrome) hyperactivity

Interventions

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-bloodte

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)