Role of Turmeric on Oxidative Modulation in ESRD Patients

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01906840

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Failure	Drug: Turmeric Drug: placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Evaluate the Effects of Turmeric on Oxidative Stress Markers in HD Patients

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Turmeric
Placebo Comparator: Drug: placebo,capsule Intervention is daily starch capsules 500 mg for 8 weeks	Drug: placebo

Arm

Intervention/Treatment

Experimental: 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

Drug: Turmeric

Placebo Comparator: Drug: placebo,capsule

Intervention is daily starch capsules 500 mg for 8 weeks

Drug: placebo

Outcome Measures

Primary Outcome Measures

effects of turmeric on oxidative stress markers [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maryam Pakfetrat, associated professor of shiraz Shiraz University of Medical Sciences, Shiraz University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01906840

Other Study ID Numbers:

Interventional
2483

First Posted:

Jul 24, 2013

Last Update Posted:

Jul 24, 2013

Last Verified:

Jul 1, 2013

Keywords provided by Maryam Pakfetrat, associated professor of shiraz Shiraz University of Medical Sciences, Shiraz University of Medical Sciences

Chronic renal failure

Hemodialysis

Oxidative stress

Turmeric

Additional relevant MeSH terms:

Renal Insufficiency

Kidney Failure, Chronic

Study Results

No Results Posted as of Jul 24, 2013