Peritoneal Dialysis Patients
Conditions
Brief summary
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic and Dr.najafi's clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of Lp (a), MDA, hs-CRP, sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH, triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine, pentosidine, glucose, albumin, calcium and phosphorous will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing
Interventions
DIETARY_SUPPLEMENTsoy isoflavone
100 mg soy isoflavone (as 2 capsules)
OTHERplacebo
2 capsules of placebo
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35
Exclusion criteria
infections inflammatory diseases; liver diseases; past medical history of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| E-selectin | 8 weeks | Serum concentrations of E-selectin |
| total cholesterol | 8 weeks | Serum concentrations of total cholesterol |
| HDL-C | 8 weeks | Serum concentrations of High-density lipoprotein cholesterol |
| LDL-C | 8 weeks | Serum concentrations of low-density lipoprotein cholesterol |
| sVCAM-1 | 8 weeks | Serum concentrations of Soluble vascular adhesion molecule-1 |
| Lp (a) | 8 weeks | Serum concentrations of lipoprotein-a |
| MDA | 8 weeks | Serum concentrations of malondialdehyde |
| hs-CRP | 8 weeks | Serum concentrations of high sensitivity c-reactive protein |
| sICAM-1 | 8 weeks | Serum concentrations of Soluble intercellular adhesion molecule-1 |
| bone alkaline phosphatase | 8 weeks | Serum concentrations of bone alkaline phosphatase |
| osteocalcin | 8 weeks | Serum concentrations of osteocalcin |
| N-telopeptide | 8 weeks | Serum concentrations of N-telopeptide |
| Osteoprotegerin | 8 weeks | Serum concentrations of Osteoprotegerin |
| RANKL | 8 weeks | Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand |
| triglyceride | 8 weeks | Serum concentrations of triglyceride |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| calcium | 8 weeks | Serum concentrations of calcium |
| phosphorous | 8 weeks | Serum concentrations of phosphorous |
| iPTH | 8 weeks | Serum concentrations of Intact parathyroid hormone |
| albumin | 8 weeks | Serum concentrations of albumin |
Countries
Iran
Contacts
Primary Contactzahra yari
Outcome results
None listed