NCT01874106
Completed
Not Applicable
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Maryam Ekramzadeh, PhD1 site in 1 country120 target enrollmentOctober 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammation
- Sponsor
- Maryam Ekramzadeh, PhD
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in serum Albumin
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effect of especial diet therapy "Anti-inflammatory Diet" on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(PEW) in hemodialysis patients.
Investigators
Maryam Ekramzadeh, PhD
PhD
Shiraz University of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Patients who are on hemodialysis(HD) at least two times a week for 3months or more without any internment illness or admission
Exclusion Criteria
- •Hospitalization because of sepsis or surgery 3 months prior to intervention
- •Cirrhosis
- •Hepatitis virus infection
- •Human Immunodeficiency virus infection
- •Acquired Immunodeficiency Syndrome
- •Active malignancy
- •Active infection
- •Absence of communication
- •Mental Impairment
- •Terminal illness
Outcomes
Primary Outcomes
Change in serum Albumin
Time Frame: 10 weeks
Secondary Outcomes
- Change in Subjective Global Assessment (SGA) score(10 weeks)
- Change in Malnutrition-inflammation score(MIS)(10 weeks)
- Change in serum C-Reactive Protein(CRP)(10 weeks)
- Change in serum malondialdehyde(MDA)(10 weeks)
- Change in serum Interleukin-6(IL-6)(10 weeks)
- Change in serum total antioxidant capacity(TAC)(10 weeks)
- Change in serum ferritin(10 weeks)
- Change in serum total iron binding capacity(TIBC)(10 weeks)
- Change in serum urea nitrogen(10 weeks)
- Change in serum creatinine(10 weeks)
- Change in serum phosphorus(10 weeks)
- Change in body fat mass index(BFMI)(10 weeks)
- Change in fat free mass index(FFMI)(10 weeks)
- Change in body cell mass(BCM)(10 weeks)
Study Sites (1)
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