The effect of curcumin supplementation on cardiovascular risk factors and kidney function on patients with stage 3 and 4 of chronic kidney disease (CKD)

The main purpose of this study is to determine the effects of Curcumin on Lipid profile of serum and Homocysteine in patients with stages 3 and 4 of CKD.

In this randomised double-blind clinical trial study,Randomization is performed through termuted blocked randomization.Sixty patients will be assigned to one of the intervention or placebo groups by using quadratic blocks and random number tables

60 patients referred to Al-Zahra hospital will be randomly divided into two groups.The intervention group will receive Curcumin supplementation for 14 weeks, 500 mg, 1 time per day and the control group will receive placebo once a day. At the beginning of the study 5 ml of venous blood (for profiling of blood lipids and Homocysteine markers ) is taken from all patients. All patients are asked not to change their diets and physical activities during the study and inform every kind of change in their consuming drugs to researchers. At the end of the study 5 ml blood is taken. For evaluation of dieting intake, 3 days food record will be gathered from each subject prior to the study, and at the end (after 14 weeks) of study.

Inclusion criteria :Ages between 18 to 75 years old ,GFR:15-29 and GFR:30-59, no infectious diseases particularly Hepatitis, not-consuming steroidal anti-inflammatory drugs, Nicotinic Acid, estrogen, progesterone and Curcumin supplementation at least 1 month before the beginning of the study.

The intervention group will receive Curcumin supplementation for 14 weeks, and the control group will receive placebo .

The primary variables in this study are measuring : Triglycerides, Cholesterol, LDL, HDL and Homocysteine and secondary variables are measuring: Urea, Creatinine, Albumin, and BMI.

Randomization will be done through the randomization blocking method (permuted blocked randomization). Considering the sample size, each block includes 4 characters and will use AAAB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient.

For the purpose of blinlding , the drug and the placebo are manufactured by the manufacturer in a way that is similar in appearance, shape, color and odor.Based on randomization of four-digit codes designed by Statistics Consultant and pasted on supplement and placebo packages.The researcher and the patient are not aware of the type of intervention.