Role of Turmeric on Oxidative Modulation in ESRD Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maryam Pakfetrat, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01906840
First received: July 21, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
End Stage Renal Failure
Drug: Turmeric
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluate the Effects of Turmeric on Oxidative Stress Markers in HD Patients

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • effects of turmeric on oxidative stress markers [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Exclusion Criteria:

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Maryam Pakfetrat, associated professor of shiraz Shiraz University of Medical Sciences, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01906840     History of Changes
Other Study ID Numbers: Interventional, 2483
Study First Received: July 21, 2013
Last Updated: July 23, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
Chronic renal failure
Hemodialysis
Oxidative stress
Turmeric

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2014