Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease

Proteinuria Clinical Trial

Official title:

Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831193
• Other study ID #: 12-793
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2013
• Last updated: July 23, 2014
• Start date: February 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health SecretariatMexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the oral supplementation with curcumin reduces proteinuria in patients with chronic kidney disease regardless the ethiology.

Description:

Curcumin is a potent antioxidant found in extracts of the rhizome of the plant Curcuma longa L.

Different studies have demonstrated that curcumin has potent biological activity and therefore is an effective therapeutic agent for the treatment of various ailments.

This compound acts as a bifunctional antioxidant:

ه is capable of reacting directly with highly reactive oxygen species. ه acts indirectly by its ability to induce the expression of various cytoprotective proteins through Keap1/Nrf2/ARE pathway.

Although RAAS blockade is the cornerstone to prevent the progression of proteinuric nephropathy, a significant number of patients remained with proteinuria and progress to end-stage renal disease.

Due to the low cost and few side effects of curcumin, this could become an adjuvant treatment of proteinuric nephropathy purposes attenuate the progression of chronic kidney disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of proteinuric chronic kidney disease with 1g or more of proteins in a daily recollection.

• Individuals taking Angiotensin II Receptor Blocker or ACE inhibitors in monotherapy with maximum dose or in combination.

Exclusion Criteria:

• Hepatic damage.

• Malignancy.

• Pregnancy.

• Peritoneal or hemodialysis.

• Organ transplantation.

• Heart failure classification III or IV (New York Heart Association).

• History of chemotherapy within 2 years prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

Drug:
• Curcumin

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiologia Ignacio Chavez	Mexico city	DF

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proteinuria		8 weeks	No