Role of Turmeric on Oxidative Modulation in ESRD Patients

Phase 1

Completed

• Conditions: End Stage Renal Failure
• Interventions: Drug: placebo; Drug: Turmeric

• Registration Number: NCT01906840
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Despite advances in prevention of cardiovascular diseases, the incidence of accelerated atherosclerosis in hemodialysis (HD) patients has still remained high. Oxidative stress is considered as a major player in uremia associated morbidity and mortality in HD patients. The aim of this study was to evaluate the effects of turmeric on oxidative stress markers in HD patients.

Detailed Description

End-stage renal disease (ESRD) is a state of oxidative stress, due to uremic oxidant mediator's accumulation, the activation of phagocytic oxidative metabolism by the dialysis membrane, intravenous iron therapy and the antioxidant depletion caused by hemodialysis (HD). Some trials showed a significant benefit from antioxidant therapy on cardiovascular outcome in HD patients.

Extensive research focused on direct exogenous antioxidants including vitamin C, and vitamin E, in the treatment of cardiovascular disease. Some clinical trials showed no more beneficial effect of exogenous antioxidant supplementation in cardiovascular disease (CVD) and recommended the necessity for a new approach to regulating cellular redox status.

Turmeric (Curcuma longa Linn) is an herb used as a dietary spice and in traditional medicine for centuries. Curcumin, the most active and non-toxic component of turmeric, is a polyphenol, which has been extensively studied for its therapeutic benefits, such as antioxidant. Besides, turmeric has also been effective in attenuation of proteinurea in diabetic nephropathy and lupus nephritis patients.

Curcumin restored the activities of mitochondrial enzymes complexes and thereby attenuated the release of reactive oxygen species. Turmeric appears to be non-toxic to humans even at high doses. However, there is a paucity of information on the effect of turmeric in HD population. We have, therefore, followed up this study to determine the beneficial effect of turmeric on oxidative stress in HD patients.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-07
• Study First Submitted: 2013-07-21
• Study First Submitted QC: 2013-07-23
• Last Update Submitted: 2013-07-23
• Study First Posted: 2013-07-24
• Last Update Posted: 2013-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• having the age of 18 years and more,
• receiving 4-hour HD treatments 3 times per week at least for three months,
• administering no other antioxidant medications

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: placebo,capsule	placebo	Intervention is daily starch capsules 500 mg for 8 weeks
drug: turmeric capsule	Turmeric	Intervention is turmeric (one capsule with each meal containing 500 mg turmeric, of which 22.1 mg was the active ingredient curcumin; three capsules daily) for 8 weeks

Primary Outcome Measures

Name	Time	Method
effects of turmeric on oxidative stress markers	8 weeks