NCT01831193

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

April 9, 2013

Last Update Submit

July 23, 2014

Conditions

Proteinuria

Outcome Measures

Primary Outcomes (1)

  • Change in proteinuria

    8 weeks

Study Arms (2)

Diabetic

ACTIVE COMPARATOR
Drug: Curcumin

Non-diabetic

ACTIVE COMPARATOR
Drug: Curcumin

Interventions

CurcuminDRUG
Also known as: Turmeric
DiabeticNon-diabetic

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (1)

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PMID: 37916745DERIVED

MeSH Terms

Conditions

Proteinuria

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 15, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

ME(1)