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The Effects of One Month Consumption of Standardized Aronia Melanocarpa Extract on Anemia in Patients on Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208451
Recruitment Status : Terminated (All required data are already collected.)
First Posted : December 23, 2019
Last Update Posted : December 24, 2019
Sponsor:
Collaborator:
Pharmanova d.o.o., Obrenovac, Serbia
Information provided by (Responsible Party):
Isidora Milosavljevic, University of Kragujevac

Brief Summary:
In this study are included patients on hemodialysis with anemia (levels of Hemoglobin<110). After baseline measurements tha patients take Standardized Aronia melanocarpa extract for one mont and then all measurements were repeated.

Condition or disease Intervention/treatment Phase
Renal Disease Dialysis; Complications Anemia Dietary Supplement: Alixir 400 Protect Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of One Month Consumption of Standardized Aronia Melanocarpa Extract on Anemia in Patients on Hemodialysis: Focus on Oxidative Stress and Inflammation
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis

Arm Intervention/treatment
Experimental: Experimental group
Patients on hemodialysis who consumed one month Standardized Aronia Melanocrpa extract
Dietary Supplement: Alixir 400 Protect
During 30 days all patients take every day 30ml of Alixir 400 protect




Primary Outcome Measures :
  1. Anemia control [ Time Frame: two months ]
    The iron levels Unit µmol/l

  2. Anemia control [ Time Frame: two months ]
    The hemoglobin levels Unit g/l

  3. Anemia control [ Time Frame: two months ]
    The ferritin levels Unit ng/ml

  4. Anemia control [ Time Frame: two months ]
    The transferrin levels Unit g/l


Secondary Outcome Measures :
  1. Oxidative stress [ Time Frame: two months ]
    Superoxide anion radical, Hydrogen peroxide, Nitrites Units nmol/ml

  2. Oxidative stress [ Time Frame: two months ]
    Superoxide dismutase, Catalase Units U/g Hb x 1000

  3. Oxidative stress [ Time Frame: two months ]
    Reduced glutathione Unit nmol/l RBC x 1000


Other Outcome Measures:
  1. Inflammation [ Time Frame: two months ]
    The parameters of inflammation CRP Unit mg/l

  2. Inflammation [ Time Frame: two months ]
    The parameters of inflammation TNF alpha Unit pg/ml

  3. Inflammation [ Time Frame: two months ]
    The parameters of inflammation white blood cells Unit x 1000000000 cells/l



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Ages Eligible for Study:   37 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • regular dialysis treatment for more than 3 months, 3 times a week
  • hemoglobin values lower than 110g / L

Exclusion Criteria:

  • hemoglobin values lower than 80g/L,
  • the use of antioxidant and immunosuppressive therapy,
  • uncontrolled malignancies,
  • proven active bleeding
  • presence of systemic inflammation or active infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208451


Locations
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Serbia
Faculty of Medical Science
Kragujevac, Serbia, 34000
Sponsors and Collaborators
University of Kragujevac
Pharmanova d.o.o., Obrenovac, Serbia
Investigators
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Principal Investigator: Isidora Milosavljevic Department of pharmacy, University of Kragujevac
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Responsible Party: Isidora Milosavljevic, Assistant professor, University of Kragujevac
ClinicalTrials.gov Identifier: NCT04208451    
Other Study ID Numbers: Alixir400protect
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isidora Milosavljevic, University of Kragujevac:
hemodialysis
anemia
oxidative stress
inflammation
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases