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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT01831193
First received: April 9, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Proteinuria
Drug: Curcumin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cardiologia Ignacio Chavez:

Primary Outcome Measures:
  • Change in proteinuria [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: February 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diabetic Drug: Curcumin
Other Name: Turmeric
Active Comparator: Non-diabetic Drug: Curcumin
Other Name: Turmeric

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831193

Locations
Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico city, DF, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
  More Information

No publications provided

Responsible Party: Magdalena Madero, MD, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT01831193     History of Changes
Other Study ID Numbers: 12-793
Study First Received: April 9, 2013
Last Updated: July 23, 2014
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
Mexico: Secretaria de Salud

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Proteinuria
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Curcumin
Turmeric extract
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014