Trial document





This trial has been registered retrospectively.
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  DRKS00015032

Trial Description

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Title

Analysis of copper- and zink-content of breast milk in women suffering from Wilson's disease

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Assessing zinc- and copper-content in the breast milk of women suffering from Wilson's disease

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Brief Summary in Scientific Language

Mothers suffering from Wilson's disease collect breast milk for 24 h every month for three months. The milk's copper and zinc-content will be measures and the baby's intake of the trace minerals will be calculated.

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Organizational Data

  •   DRKS00015032
  •   2019/08/28
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  •   yes
  •   Approved
  •   212-14, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   E83.0 -  Disorders of copper metabolism
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Interventions/Observational Groups

  •   Mothers pump and collect all milk over a 24-hour period at 4-6, 8-10 and 12-14 weeks after birth. Milk is expressed by pump into new glas containers. Both the pump-set and the Containers are flushed with aqua dest. prior to use. Mothers put the milk into the freezer and store it at home until transfer to the lab. The Infant ist fed formula at the days of milk sampling. The total amount of consumed milk is noted in a protocol. Analyses for copper and zinc contend are done at the Institute for Laboratory Medicine of Munich University Hospital.
    The copper and zink content, the amount of expressed milk and the amount of milk consumed by the infant let us calculate the infant's intake of the trace minerals copper and zinc. The calculated intake will be compared to the recommended daily intake (according to ESPHAGAN recommendations, Koletzko, 2005).
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

An analysis of the copper- and zinc-concentration in breastmilk as well as a calculation of the infant's copper and zinc intake at the days of milk sampling had he/she been exclusively breastfed will be done in this study.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/09/24
  •   5
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Breastfeeding mothers, Diagnosis of Wilson's disease

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Exclusion Criteria

Problems with breastfeeding

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Addresses

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    • Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital, Neonatologie am Perinatalzentrum Großhadern
    • Mr.  Prof  Andreas  Schulze 
    • Marchioninistr 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern
    • Mr.  Tobias  Reicherzer 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern
    • Mr.  Tobias  Reicherzer 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Dr. von Haunersches KinderspitalNeonatologie am Perinatalzentrum Großhadern
    • Marchioninistr 15
    • 81377  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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