Trial document





This trial has been registered retrospectively.
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  DRKS00004768

Trial Description

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Title

Multicenter-study to evaluate the supply of micronutrients of PKU-patients 7 years and older under a relaxed diet (phenylalanin-tolerance >800 mg/d)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Phenylketonuria is an inborn disease, which leads to severe physical and mental disability. Therapy consists of a very strict lifelong diet. To avoid protein-, vitamin- and mineral deficiencies, as the patients’ choice of natural food is extremely limited, a supplement has to be added to the diet. It contains significant amounts of precursors of protein, vitamins and minerals. Patients with a mild course of the disease who can follow a relaxed diet with only a low dosage of the supplement might be at risk of insufficient vitamin and mineral supply. We evaluate dietary records of patients with a high tolerance of natural foods to investigate whether or not the supply of vitamins and minerals is sufficient.

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Brief Summary in Scientific Language

Phenylketonuria is an inborn metabolic disease, which leads to severe physical and mental disability. Therapy consists of a lifelong phenylalanin restricted diet. To avoid protein- and micronutrient deficiencies, as the patients’ choice of natural food is extremely limited, an amino acid mixture (AAM) has to be added to the diet. It contains significant amounts of micronutrients as well. Patients with a mild course of the disease who can follow a relaxed diet with only a low dosage of AAM might be at risk of insufficient micronutrient supply. We evaluate dietary records of patients with a high phenylalanin tolerance to investigate whether or not the micronutrient supply is sufficient.

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Organizational Data

  •   DRKS00004768
  •   2013/02/28
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  •   yes
  •   Approved
  •   035-11-24012011, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   E70.0 -  Classical phenylketonuria
  •   E70.1 -  Other hyperphenylalaninaemias
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Interventions/Observational Groups

  •   PKU-patients write a diet diary over 3 days and fill in a quality of life questionaire.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Nutritional behaviour measured at the daily supply of energy, protein, phenylalanin, carbohydrates, fat, calcium, vitamin D, vitamin B1, B2 and B12, iron, folic acid, zinc, selen, vitamin C, iodine

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Secondary Outcome

Qualitiy of life, measured with validated questionaires: KINDL (questionaire to determine health regarded quality of life for children and adolescents) and FLZ (questionaire to determine contentment of life) for patients 17 years and older.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/04/06
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   7   Years
  •   100   Years
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Additional Inclusion Criteria

- PKU-patients with a phe tolerance >800 mg/day
- PKU-patients which are healthy at the time of recruiting

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Exclusion Criteria

- patients with psychological disorders
- epilepsy
- allergies
- infections
- chronical diseases following surgery at the gut, which influence the resorption, metabolism or secretion of food
- other metabolic diseases besides PKU
- using drugs regularily, exept the amino acid mixture and Sapropterin (Kuvan)
- dystrophy (body weight <5th percentile)
- other diets besides the PKU-diet
- using supplements, besides the amino acid mixture

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Addresses

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    • Universität Leipzig
    • Augustusplatz 10
    • 04109  Leipzig
    • Germany
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    • Universitätsklinik und Poliklinik für Kinder und Jugendliche
    • Ms.  Dipl. oec.troph.  Carmen  Rohde 
    • Liebigstraße 20a
    • 04103  Leipzig
    • Germany
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    • Universitätsklinik und Poliklinik für Kinder und Jugendliche
    • Ms.  Dipl. oec.troph.  Carmen  Rohde 
    • Liebigstraße 20a
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • NUTRICIA GmbH - SHS Geschäftsstelle Heilbronn
    • Happenbacher Straße 5
    • 74074  Heilbronn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/10/31
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Trial Publications, Results and other Documents

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