Trial document




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  DRKS00000724

Trial Description

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Title

Effect of a dietary supplement purposes in patients with osteoarthritis - Randomized, placebo-controlled, double-blind intervention study

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Trial Acronym

Osteoarthritis study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the planned intervention study is to investigate to what extent a nutrient supplement compared to placebo change in pain in osteoarthritis (especially osteoarthritis in the knee) can be achieved. In this intervention a nutritional supplement with the ingredients glucosamine, chondoitin sulfate, hyaluronic acid, vitamin C, vitamin D, and selenium is tested. Same time, the supply in the nutrient status of the supplement containing substances are detected and assessed.

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Brief Summary in Scientific Language

Symptom modifying effects of a nutrient supplement in patients with osteoarthritis in the knee (gonarthrosis)

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Organizational Data

  •   DRKS00000724
  •   2011/06/01
  •   [---]*
  •   yes
  •   Approved
  •   011/1490, Freiburger Ethik-Kommission International
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Secondary IDs

  •   U1111-1121-2961 
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Health Condition or Problem studied

  •   M17.0 -  Primary gonarthrosis, bilateral
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Verum: 2x2 capsules per day, nutrient supplements with ingredients glucosamine, chondroitin sulfate, hyaluronic acid, vitamin C, vitamin D and selenium
  •   Placebo: 2x2 placebo capsules per day
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
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  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

WOMAC Score (Questionnaire), Measurement of changes after 24 weeks compared to baseline

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Secondary Outcome

generel health (questionnaire): at baseline and after 6, 12, 18 and 24 weeks - blood parameters (blood count, liver enzymes, glucose, HbA1c, blood lipids, hsCRP, vitamin C, vitamin D, selenium, glutathione peroxidase) (blood samples): at baseline and after 6, 12, 18 and 24 weeks- documentation of acute medication (questionnaire and diary): at baseline and after 6, 12, 18 and 24 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/10/11
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Men and women >18 years - diagnosed gonarthrosis - WOMAC subscore pain >/=15 points, >/=150 mm, respectively

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Exclusion Criteria

allergy or intolerance to any component of the test product - severe chronic diseases (tumors etc) - severe cardiovascular disease, renal failure, liver disease - chronic inflammatory joint diseases, infectious diseases of the joints - classification of Kellgren stage IV - BMI >40 kg/m² - chronic diseases of the gastrointestinal tract - taking additional glucosamine, chondroitin and hyaluronic acid-containing products before or during the study - intra-articular injections - intra-articular and systemic corticosteroid therapy - pain relief or ointments during the study - pregnancy and lactation - alcohol, drug addiction - incapacitated subjects - refusal or withdrawal of consent by the subjects - simultaneous participation in another clinical study or participation within the past 30 days

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Addresses

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    • Leibniz Universtiät Hannover Institut für Lebensmittelwissenschaft und Humanernährung
    • Mr.  Prof. Dr.   Andreas  Hahn 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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    • Leibniz Universtiät Hannover Institut für Lebensmittelwissenschaft und Humanernährung
    • Mr.  Prof. Dr.   Andreas  Hahn 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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    • Leibniz Universität Hannover Institut für Lebensmittelwissenschaft und Humanernährung
    • Ms.  Dr.   Inga  Schneider 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • ROTTAPHARM | MADAUS
    • 51067  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/04/23
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.