Study Stopped
All required data are already collected.
The Effects of One Month Consumption of Standardized Aronia Melanocarpa Extract on Anemia in Patients on Hemodialysis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedDecember 24, 2019
December 1, 2019
2 months
December 18, 2019
December 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Anemia control
The iron levels Unit µmol/l
two months
Anemia control
The hemoglobin levels Unit g/l
two months
Anemia control
The ferritin levels Unit ng/ml
two months
Anemia control
The transferrin levels Unit g/l
two months
Secondary Outcomes (3)
Oxidative stress
two months
Oxidative stress
two months
Oxidative stress
two months
Other Outcomes (3)
Inflammation
two months
Inflammation
two months
Inflammation
two months
Study Arms (1)
Experimental group
EXPERIMENTALPatients on hemodialysis who consumed one month Standardized Aronia Melanocrpa extract
Interventions
During 30 days all patients take every day 30ml of Alixir 400 protect
Eligibility Criteria
You may qualify if:
- regular dialysis treatment for more than 3 months, 3 times a week
- hemoglobin values lower than 110g / L
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kragujevaclead
- Pharmanova d.o.o., Obrenovac, Serbiacollaborator
Study Sites (1)
Faculty of Medical Science
Kragujevac, 34000, Serbia
Related Publications (1)
Milosavljevic I, Jakovljevic V, Petrovic D, Draginic N, Jeremic J, Mitrovic M, Zivkovic V, Srejovic I, Stojic V, Bolevich S, Andjelkovic N. Standardized Aronia melanocarpa extract regulates redox status in patients receiving hemodialysis with anemia. Mol Cell Biochem. 2021 Nov;476(11):4167-4175. doi: 10.1007/s11010-021-04225-y. Epub 2021 Jul 29.
PMID: 34327604DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isidora Milosavljevic
Department of pharmacy, University of Kragujevac
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
December 18, 2019
First Posted
December 23, 2019
Study Start
August 1, 2019
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
December 24, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share