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

July 21, 2013
July 23, 2013
April 2011
August 2012   (final data collection date for primary outcome measure)
effects of turmeric on oxidative stress markers [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01906840 on ClinicalTrials.gov Archive Site
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Role of Turmeric on Oxidative Modulation in ESRD Patients
Evaluate the Effects of Turmeric on Oxidative Stress Markers in HD Patients

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
End Stage Renal Failure
  • Drug: Turmeric
  • Drug: placebo
  • 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
    Intervention: Drug: Turmeric
  • Placebo Comparator: Drug: placebo,capsule
    Intervention is daily starch capsules 500 mg for 8 weeks
    Intervention: Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2012
August 2012   (final data collection date for primary outcome measure)

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:

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01906840
Interventional, 2483
No
Maryam Pakfetrat, Shiraz University of Medical Sciences
Shiraz University of Medical Sciences
Not Provided
Not Provided
Shiraz University of Medical Sciences
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP