NCT01906840

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

July 21, 2013

Last Update Submit

July 23, 2013

Conditions

End Stage Renal Failure

Keywords

Chronic renal failureHemodialysisOxidative stressTurmeric

Outcome Measures

Primary Outcomes (1)

  • effects of turmeric on oxidative stress markers

    8 weeks

Study Arms (2)

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

TurmericDRUG
drug: turmeric capsule
placeboDRUG
Drug: placebo,capsule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor of shiraz Shiraz University of Medical Sciences

Study Record Dates

First Submitted

July 21, 2013

First Posted

July 24, 2013

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 24, 2013

Record last verified: 2013-07