Effect of Curcumin on the Reduction of Cellular Inflammation Markers in Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Interleukin Interleukin-6
研究概览
简要总结
The goal of this clinical trial is to learn if curcumin can lower the inflammation in participants with chronic kidney disease (CKD) undergoing hemodialysis (HD).
The main questions it aims to answer are:
Does curcumin lower can lower profinflamatory markers in participants with CKD on HD?
Researchers will compare curcumin to a placebo (a look-alike substance that contains no drug) to see if curcumin works to help the treatment in participants with CKD on HD.
Researchers will compare nutritional status and side effects after taking the supplement.
Participants will:
Take the curcumin or a placebo twice a day for 3 months Visit the clinic once every week for checkups and tests.
详细描述
- Study Title:
"Effect of Curcumin on the Reduction of Cellular Inflammation Markers in Hemodialysis Patients" 2. Study Design:
Type: Randomized, double-blind, placebo-controlled clinical trial.
- Setting: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde," Mexico.
- Participants: 34 CKD patients on hemodialysis or peritoneal dialysis, aged 18+.
- Intervention: Patients will receive either curcumin (500 mg capsules, 3 times daily) or placebo for 12 weeks with pre- and post-intervention assessments.
- Objectives:
Primary Objective: To evaluate the effect of curcumin supplementation on inflammatory markers (TNF-α, IL-1β, IL-6, and CRP) in hemodialysis patients.
Secondary Objectives:
- To assess changes in renal metabolites (creatinine, urea, proteinuria).
- To monitor nutritional status (weight, BMI, muscle mass, dynamometry).
- To identify potential side effects or adverse reactions associated with curcumin supplementation.
- Study Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes undergoing dialysis or hemodialysis.
- •Aged 18 years or older.
- •Clinically stable and receiving hemodialysis or dialysis for at least three months before study enrollment.
- •Continuation of pharmacotherapy as prescribed by their physician.
- •Regular use of antioxidant supplements and turmeric consumption.
- •Signed written informed consent.
排除标准
- •Active malignant disease (diagnosed within the past five years).
- •Critical illness requiring respiratory or circulatory support.
- •Severe congestive heart failure (NYHA class IV).
- •Severe chronic systemic infectious or inflammatory disease.
- •Severe liver disease.
- •Known allergy to study products.
- •Treatment with immunosuppressants or experimental drugs in the past month.
- •Use of anti-inflammatory corticosteroids.
- •Scheduled kidney transplant during the study.
- •Pregnant patients.
- •Active smokers.
- •Autoimmune diseases, cancer, severe infections, or AIDS.
研究组 & 干预措施
case group
curcumin capsules 500 mg every 8 hours for 12 weeks
干预措施: Curcumin (Longvida™) (Dietary Supplement)
control group
placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Interleukin Interleukin-6
时间窗: after 3 months of supplementation
final meassurement of Interleukin-6 nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
TNF-α: Tumor Necrosis Factor-alpha
时间窗: after 3 months of supplementation
final meassurement of TNF-α in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
IL-1β: Interleukin-1 beta
时间窗: after 3 months of supplementation
final meassurement of IL-1β in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
次要结局
- Urea(after 3 months of supplementation)
- leukocyte count(after 3 months of supplementation)
- neutrophil/lymphocyte ratio (NLR)(after 3 months of supplementation)
- lymphocyte/platelet ratio (LPR)(after 3 months of supplementation)
- erythrocyte sedimentation rate (ESR)(after 3 months of supplementation)
- serum albumin(after 3 months of supplementation)
- BMI(after 3 months of supplementation)
- Weight(after 3 months of supplementation)
- body mass index (BMI)(before supplementation)
- body fat percentage(after supplementation)
- muscle mass(after 3 months of supplementation)
- hand grip strenght(after 3 months of supplementation)
研究者
Mariana Chávez-Tostado
Doctor in Multidisciplinary Health Research
University of Guadalajara