Clinical trial NCT04072341: Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients.
Official title: Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients: a Randomized Cross-over Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: Inflammation
Propolis
High-sensitivity C-reactive protein
Hemodialysis
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Sao Rafael
name: Alagoas State University of Health Science , Maceió , Brazil.
First posted: 2019-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective, open-label, proof-of-concept, single-center. Each patient served as their own control.
Primary purpose: TREATMENT

Brief summary: End-stage chronic kidney disease is associated with the condition of chronic inflammation. Patients on hemodialysis are known to be predisposed to several factors that predispose to inflammation: dialysis membranes, central venous catheters, oxidative stress, fluid overload, sodium overload, uraemic toxins. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, and anti-oxidant properties. The aim of this study was to evaluate the impact of Brazilian green propolis extract on inflammation in hemodialysis patients.

Detailed description: Randomized open-label cross-over trial to investigate impact of Brazilian green propolis extract on inflammation in hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years;
* Male or female on hemodialysis for at least 1 month.

Exclusion Criteria:

* Pregnant Woman;
* Carriers of active neoplasms;
* Patients undergoing kidney transplantation during the study;
* Infection during the study;
* Patients who underwent parathyroidectomy during the study;
* Patient using immunosuppressive drugs;
* Allergy to propolis or any of its components;

Primary outcomes:
measure: Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in serum level of Interleukin-1 Beta from baseline to end of study periods.
timeFrame: 8 weeks
measure: Changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study, from baseline to end of study periods.
timeFrame: 8 weeks
measure: Percentage of participants with adverse events during the study.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Marcelo Augusto Duarte Silveira
state: Bahia
Study officials:
affiliation: Hospital São Rafael S.A
name: Marcelo Silveira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Estadual de Ciências da Saúde de Alagoas
name: Flávio Teles, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Rafael S.A
name: Rogério Passos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teles F, da Silva TM, da Cruz Junior FP, Honorato VH, de Oliveira Costa H, Barbosa AP, de Oliveira SG, Porfirio Z, Liborio AB, Borges RL, Fanelli C. Brazilian red propolis attenuates hypertension and renal damage in 5/6 renal ablation model. PLoS One. 2015 Jan 21;10(1):e0116535. doi: 10.1371/journal.pone.0116535. eCollection 2015.
citation: Dai L, Golembiewska E, Lindholm B, Stenvinkel P. End-Stage Renal Disease, Inflammation and Cardiovascular Outcomes. Contrib Nephrol. 2017;191:32-43. doi: 10.1159/000479254. Epub 2017 Sep 14.
citation: Silveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7.
citation: Cobo G, Lindholm B, Stenvinkel P. Chronic inflammation in end-stage renal disease and dialysis. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii35-iii40. doi: 10.1093/ndt/gfy175.