Role of Turmeric on Oxidative Modulation in ESRD Patients | NCT01906840

Studies
Role of Turmeric on Oxidative Modulation in ESRD Patients

NCT01906840

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Jul 24, 2013Estimated

Enrollment

48Actual

Phase

Phase 1Phase 2

Conditions

End Stage Renal Failure

Interventions

Turmeric
placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2483	Other Identifier	snurc

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jul 21, 2013

First Submission Date that Met QC Criteria

Jul 23, 2013

First Posted Date

Jul 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2013

Last Update Posted Date

Jul 24, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Shiraz University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
drug: turmeric capsule	Experimental	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
Drug: placebo,capsule	Placebo Comparator	Intervention is daily starch capsules 500 mg for 8 weeks	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Turmeric	Drug		drug: turmeric capsule
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effects of turmeric on oxidative stress markers		8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003474	Curcumin

Ancestor Terms

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided