Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

NCT03144882 | Completed DMC

• 1 other identifier: TUR21324354
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

Programmed ingestion of turmeric has no adverse effects and reduces plasma level of hs-CRP, IL-6 and TNF-α accompanying with increases albumin levels in hemodialysis patients. Turmeric can be considered as an effective anti-inflammatory supplement in hemodialysis patients.

Conditions

Hemodialysis Complication; Hemodialysis-Induced Symptom

Outcome Measures

Primary Outcomes (1)

• Mean Interlukin-6 Levels

  blood even

  one year

Study Arms (2)

intervention

ACTIVE COMPARATOR

the trial group (n =35 )

Drug: Curcumin Pill

placebo

PLACEBO COMPARATOR

control group

Drug: Placebo

Interventions

Curcumin Pill DRUG

Turmeric rhizome at first was washed and dried out in a warm and dry place for a week , then powdered rhizomes were encapsulated by Clinical Pharmacy Research Center of Shahid Beheshti University of Medical Sciences, using hard gelatin capsules. Also placebo capsules were made by the same center using Sorbitol. Curcumin level of turmeric was measured by HPTLC analysis for quantification of variability in content of curcumin

intervention

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 year
• Clinically stable and receiving adequate hemodialysis defined by a single pool Kt/V≥1.20 or no less than 3 dialysis sessions per week with a total dialysis time ≥12 hour per week for at least 3 month before enrollment,
• Diabetic patients must be willing to commence insulin therapy if deemed necessary for plasma glucose control.

You may not qualify if:

• Active malignant disease (defined as less than 5 year since receiving a diagnosis of being malignancy-free)
• Critical illness as defined by the need for respiratory or circulatory support (in an intensive care unit)
• Active vasculitis
• Severe congestive heart failure (New York Heart Association class IV)
• Severe chronic systemic infectious or inflammatory disease
• Liver disease (defined as serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of normal)
• Known or suspected allergy to trial product(s) or related products
• Treatment with immunosuppressive agents or receipt of any investigational drug within one month preceding screening
• Recent or current use of anti-inflammatory corticosteroids agents
• A scheduled renal transplantation within the trial period

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Related Publications (1)

• Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

  PMID: 37916745 DERIVED

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of SBMU

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: February 2, 2015
• Primary Completion: February 2, 2016
• Study Completion: February 2, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share