Effect of Oral Supplementation With Curcumin in Patients With Proteinuric Diabetic Kidney Disease
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to determine if the oral supplementation with curcumin reduces proteinuria, improves the redox and pro-inflammatory state in patients with chronic kidney disease associated to Diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJanuary 13, 2017
September 1, 2016
1 year
September 12, 2016
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urine protein excretion
Quantify proteinuria and adjust based in creatinuria, before and after the treatment. ( Units: g/g).
24 weeks
Secondary Outcomes (3)
Free radical scavenging activity
6 months
Malondialdehyde (MDA)
6 months
Proinflammatory status
6 months
Study Arms (2)
Curcumin
EXPERIMENTALEach patient of this group will receive 1.67 grams of curcumin ( 7 capsules of 231 mg) divided in 3 doses daily for 6 months.
Placebo
PLACEBO COMPARATORThe control group will receive 7-capsules/ day identical in color and size, containing placebo for 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Diabetes Mellitus type 2 and proteinuric kidney disease with 1000 mg of more proteins in daily recollection
- Glomerular filtration rate between 15-60 mL/min/ 1.73 m2 calculated by CKD-EPI
- Patients taking Angiotensin II Receptor Blocker or ACE inhibitors
You may not qualify if:
- Renal replacement therapy
- Autoimmune disease or malignancy
- Pregnancy
- Hepatic damage
- Congestive heart failure classification III or IV (NYHA)
- History of organ transplantation
- History of chemotherapy or immunosuppression within 2 years prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Cardiologia Ignacio Chávez
Mexico City, Mexico City, 14080, Mexico
Related Publications (5)
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PMID: 11904577BACKGROUNDde Zeeuw D, Remuzzi G, Parving HH, Keane WF, Zhang Z, Shahinfar S, Snapinn S, Cooper ME, Mitch WE, Brenner BM. Proteinuria, a target for renoprotection in patients with type 2 diabetic nephropathy: lessons from RENAAL. Kidney Int. 2004 Jun;65(6):2309-20. doi: 10.1111/j.1523-1755.2004.00653.x.
PMID: 15149345BACKGROUNDTrujillo J, Chirino YI, Molina-Jijon E, Anderica-Romero AC, Tapia E, Pedraza-Chaverri J. Renoprotective effect of the antioxidant curcumin: Recent findings. Redox Biol. 2013 Sep 17;1(1):448-56. doi: 10.1016/j.redox.2013.09.003.
PMID: 24191240BACKGROUNDKhajehdehi P, Pakfetrat M, Javidnia K, Azad F, Malekmakan L, Nasab MH, Dehghanzadeh G. Oral supplementation of turmeric attenuates proteinuria, transforming growth factor-beta and interleukin-8 levels in patients with overt type 2 diabetic nephropathy: a randomized, double-blind and placebo-controlled study. Scand J Urol Nephrol. 2011 Nov;45(5):365-70. doi: 10.3109/00365599.2011.585622. Epub 2011 May 31.
PMID: 21627399BACKGROUNDJimenez-Osorio AS, Garcia-Nino WR, Gonzalez-Reyes S, Alvarez-Mejia AE, Guerra-Leon S, Salazar-Segovia J, Falcon I, Montes de Oca-Solano H, Madero M, Pedraza-Chaverri J. The Effect of Dietary Supplementation With Curcumin on Redox Status and Nrf2 Activation in Patients With Nondiabetic or Diabetic Proteinuric Chronic Kidney Disease: A Pilot Study. J Ren Nutr. 2016 Jul;26(4):237-44. doi: 10.1053/j.jrn.2016.01.013. Epub 2016 Feb 22.
PMID: 26915483BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Chief of the Nephrology Department
Study Record Dates
First Submitted
September 12, 2016
First Posted
January 13, 2017
Study Start
May 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
January 13, 2017
Record last verified: 2016-09