Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

NCT ID: NCT03144882

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-02
• Study Completion Date: 2017-02-02

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.

Detailed Description

Hemodialysis patients over 18 years were recruited after fulfilling the inclusion criteria.Seventy-one hemodialysis patients were randomized into two groups: the trial group (n =35 ) and the controls (n =36 ); a randomization numeric table was used for allocation sequence . Trial group received turmeric and control group received placebo for 12 weeks. Biochemical determinations included levels of serum albumin (Alb), potassium (K) ,blood urea nitrogen (BUN), serum creatinine (Cr), IL-6 level, TNF- α , and liver function tests and hs-CRP at the start and end of the study were measured.

Conditions

Hemodialysis Complication; Hemodialysis-Induced Symptom

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

intervention

the trial group (n =35 )

Group Type: ACTIVE_COMPARATOR

Curcumin Pill

Intervention Type: 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

placebo

control group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

Curcumin Pill

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 Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

nooshin dalili

Assistant Professor of SBMU

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 37916745 (View on PubMed)

Other Identifiers

TUR21324354

Identifier Type: -

Identifier Source: org_study_id