Role of Turmeric on Oxidative Modulation in ESRD Patients

NCT ID: NCT01906840

Last Updated: 2013-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-08-31

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.

Conditions

End Stage Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

drug: turmeric capsule

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

Group Type: EXPERIMENTAL

Turmeric

Intervention Type: DRUG

Drug: placebo,capsule

Intervention is daily starch capsules 500 mg for 8 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Turmeric

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Maryam Pakfetrat

associated professor of shiraz Shiraz University of Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2483

Identifier Type: OTHER

Identifier Source: secondary_id

Interventional

Identifier Type: -

Identifier Source: org_study_id