Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00008577

Trial Description

start of 1:1-Block title

Title

Oligoantigenic diet in children with attention deficit hyperactivity disorder - feasibility and efficacy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ADHD diet

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A possible connection between attention deficit-hyperactivity disturbance (ADHD) and food was described in the literature already at the beginning of the last century. According to numerous studies approx. 60% of the children with the diagnosis ADHD show intolerance at different food. Very clear improvements in the behaviour and the attention of the children can be achieved by avoidance of this food.
The oligoantigenic diet is used by leaving out food, that is suppossed to be a trigger for ADHD. That food often causes allergies as well.
Objective of this study is to explore if a standardized oligoantigenic diet may reduce the symptoms of children with an ADHD.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Feasibility and effectivity
An approved and admitted form of diagnosis for many allergies associated with food is the oligoantigenic diet even for children (Lepp et al., 2010) and is listed in the AWMF Guidelines of the German Society for child and adolescent psychiatry, psychosomatics and psychotherapy (DGKJP).
The protocol in detail written by L.M. Pelsser, Lancet (2011) is available and may be used after consulting the author as a model for the attentive realization of the study “Oligoantigenic diet with children with an attention deficit hyperactivity disorder“. L.M. Pelsser was already able to improve the behavior of approx. 60% of treated children for round 50% or more.
Objective of this study is to explore if a standardized oligoantigenic diet may reduce the symptoms of children with an ADHD.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008577
  •   2015/07/20
  •   [---]*
  •   yes
  •   Approved
  •   111/14_140977, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F90.0 -  Disturbance of activity and attention
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Evidence of efficacy of the oligoantigenic diet appropriate to the following procedure:
    During the phase of diagnosis (T0) a blood sample is taken, medical examination is done, data collection with K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia – Present and Lifetime Version).
    2 weeks after T0 (T1) nutrition according to extended oligoantigenic diet starts (Pelsser, 2011; Egger, 1985; Kaplan, 1989; Carter, 1993; Schulte-Körne, 1996; Hiedl, 2004). Duration of the diet is limited to 4 weeks. At that time anamnesis of nutrition is evaluated. 6 weeks after T0 (T2) there is an evaluation of the records of nutrition and symptoms and a meeting about the reintroduction of food.

    12 weeks after T0 (T3) the records of nutrition and symptoms are re-evaluated. After 12 weeks all groups of food are back in menu. The groups of food that were critical can be tested separately in the next phase.

    16 weeks after T0 (T4) a new blood sample is taken, medical examination is done, records of nutrition and symptoms are evaluated.
    After 16 weeks almost all food is back in menu. At that time there should exist a list of food that is to be avoided.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Demonstrating the effectiveness of oligoantigenic diet based on the change in ADHD symptoms before and after the diet. Parameters are measured by the ADHD Rating Scale and the parent interview, which will be collected at the time T1 and T2.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Changes in symptoms between T1 and T2, as measured by the following instruments:
CPRTS-S (short version Conners sheets for parents)
CTRS-S (short version Conners sheets for teachers)
CBCL (chield Behaviour Checklist)
ILK (instrument for assessing quality of life in children).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/10/22
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   7   Years
  •   12   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Existing Informed Consent, diagnosis ADHD according to the criteria of the DSM IV and ICD-10, visit mind. of the 2nd class of a general school.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Heavy neurological or organic comorbidities, which which don´t allow a diet.

Neurological illnesses. Also parents shouldn´t be affected.

Lack of compliance of the parents and/or the children.

Lack of readiness of the teachers.

Lack of reading or writing abilities with the parents and/or children.

No parallel therapy of the ADHD with psychostimulants or other psychiatric drugs.

Patients with special food habits (e.g.: vegetarians, vegans)

No parallel participation in other studies.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0761-270-65550
    •   0761-270-68590
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Mr.  Prof. Dr.  Christian  Fleischhaker 
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinik Freiburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Mr.  Prof. Dr.  Hans-Willi  Clement 
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0761-270-65550
    •   0761-270-68590
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.