Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD)

Chronic Kidney Disease (CKD) Clinical Trial

— MADRAD  

Official title:

Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD) - A Prospective Data Collection Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01415570
• Other study ID #: 14100
• Secondary ID: K24DK091419
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2011
• Last updated: May 20, 2015
• Start date: August 2011
• Est. completion date: November 2016

Study information

• Verified date: May 2015
• Source: Los Angeles Biomedical Research Institute
• Contact: Caludia Luna
• Phone: 310-222-2346
• Email: cluna[@]labiomed.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

In the United States, African Americans are 3.6 time and Hispanics 1.5 times more likely to suffer from chronic kidney disease and need dialysis treatment for life, when compared to the non-Hispanic Whites. Unfortunately many dialysis patients die, so that after 5 years only less than 35% are still alive. Dialysis patients who appear malnourished or who have muscle and fat wasting are even more likely to die. Interestingly, among dialysis patients, minorities (African Americans, Hispanics and Asian Americans) usually survive longer than the non-Hispanic Whites. If the investigators can discover the reasons for these so-called "racial survival disparities" of dialysis patients, the investigators may be able to improve survival for all dialysis patients and maybe even for many other people who suffer from other chronic diseases. During this 5 year study the investigators would like to test if a different nutrition and diet can explain better survival of minority dialysis patients. The investigators will also test if in additional to nutrition there are 2 other reasons for better survival of minority dialysis patients, namely differences in bone and minerals and differences in social and psychological and mental health. The investigators plan to study 450 hemodialysis patients every 6 months in several dialysis clinics in Los Angeles South Bay area. These subjects will include 30% African Americans, 30% Hispanics, 30% non-Hispanic Whites and 10% Asians. Every 6 months the investigators will examine their nutritional conditions, dietary intake, psycho-social conditions and quality of life, and will recruit 75 new subjects to replace those who left our study as a result of kidney transplantation, death or other reasons. Hence, the investigators estimate studying a total of 1,050 hemodialysis patients over 5 years. Clinical events such as hospital admissions and survival will be followed. Blood samples will be obtained every 6 months for measurements of hormones and "biomarkers", and the remainder of the blood will be stored in freezers for future measurements. The investigators plan to design and develop race and ethnicity specific nutritional risk scores and food questionnaires and will test some of these scores in larger national databases of hemodialysis patients. Almost a year after the study starts, the investigators also plan to do additional tests of body composition and dietary intake in a smaller group of these patients at the GCRC.

Description:

I. SPECIFIC AIMS & HYPOTHESES I.1.HYPOTHESES: Despite higher burden of chronic kidney disease (CKD) in minorities, they have greater survival compared to non-Hispanic Whites with CKD. The investigators hypothesize that survival advantages of minority CKD patients (pts) result from biologically plausible mechanisms related to differences in nutritional status & diet (main hypothesis) or differences in bone-&-minerals and/or psychosocial & coping status (2 alternative hypotheses). Differences in these conditions may lead to different degrees of protein-energy wasting, inflammation, oxidative stress, & platelet activation, leading to thrombo-embolic & cardiovascular (CV) events. Discovering the biology of CKD racial survival disparities may lead to improving outcomes in both CKD and others chronic diseases.

During this 5-year study the principal investigator (Dr. Kalantar-Zadeh) will also help a number of early-career investigators to design and develop additional studies including research in minority populations with chronic diseases using data and resources of this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult (18-85 yrs) patients

• HD > 4 weeks

Exclusion Criteria:

• Terminal disease with life expectancy < 6 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• End-Stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic
• Malnutrition
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Harold Simmons Center for Kidney Disease Research & Epidemiology	Torrance	California

Sponsors (3)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute	Davita Clinical Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Bross R, Chandramohan G, Kovesdy CP, Oreopoulos A, Noori N, Golden S, Benner D, Kopple JD, Kalantar-Zadeh K. Comparing body composition assessment tests in long-term hemodialysis patients. Am J Kidney Dis. 2010 May;55(5):885-96. doi: 10.1053/j.ajkd.2009.12.031. Epub 2010 Mar 25. — View Citation

Bross R, Noori N, Kovesdy CP, Murali SB, Benner D, Block G, Kopple JD, Kalantar-Zadeh K. Dietary assessment of individuals with chronic kidney disease. Semin Dial. 2010 Jul-Aug;23(4):359-64. doi: 10.1111/j.1525-139X.2010.00743.x. Epub 2010 Jul 29. Review. — View Citation

Feroze U, Noori N, Kovesdy CP, Molnar MZ, Martin DJ, Reina-Patton A, Benner D, Bross R, Norris KC, Kopple JD, Kalantar-Zadeh K. Quality-of-life and mortality in hemodialysis patients: roles of race and nutritional status. Clin J Am Soc Nephrol. 2011 May;6(5):1100-11. doi: 10.2215/CJN.07690910. Epub 2011 Apr 28. — View Citation

Kalantar-Zadeh K, Golan E, Shohat T, Streja E, Norris KC, Kopple JD. Survival disparities within American and Israeli dialysis populations: learning from similarities and distinctions across race and ethnicity. Semin Dial. 2010 Nov-Dec;23(6):586-94. doi: 10.1111/j.1525-139X.2010.00795.x. Review. — View Citation

Kalantar-Zadeh K, Kovesdy CP, Bross R, Benner D, Noori N, Murali SB, Block T, Norris J, Kopple JD, Block G. Design and development of a dialysis food frequency questionnaire. J Ren Nutr. 2011 May;21(3):257-62. doi: 10.1053/j.jrn.2010.05.013. Epub 2010 Sep 15. — View Citation

Kalantar-Zadeh K, Kovesdy CP, Derose SF, Horwich TB, Fonarow GC. Racial and survival paradoxes in chronic kidney disease. Nat Clin Pract Nephrol. 2007 Sep;3(9):493-506. Review. — View Citation

Molnar MZ, Streja E, Kovesdy CP, Budoff MJ, Nissenson AR, Krishnan M, Anker SD, Norris KC, Fonarow GC, Kalantar-Zadeh K. High platelet count as a link between renal cachexia and cardiovascular mortality in end-stage renal disease patients. Am J Clin Nutr. 2011 Sep;94(3):945-54. doi: 10.3945/ajcn.111.014639. Epub 2011 Aug 3. — View Citation

Noori N, Kovesdy CP, Dukkipati R, Feroze U, Molnar MZ, Bross R, Nissenson AR, Kopple JD, Norris KC, Kalantar-Zadeh K. Racial and ethnic differences in mortality of hemodialysis patients: role of dietary and nutritional status and inflammation. Am J Nephrol. 2011;33(2):157-67. doi: 10.1159/000323972. Epub 2011 Feb 4. — View Citation

Streja E, Kovesdy CP, Molnar MZ, Norris KC, Greenland S, Nissenson AR, Kopple JD, Kalantar-Zadeh K. Role of nutritional status and inflammation in higher survival of African American and Hispanic hemodialysis patients. Am J Kidney Dis. 2011 Jun;57(6):883-93. doi: 10.1053/j.ajkd.2010.10.050. Epub 2011 Jan 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		5-years (60 months)	No
Secondary	Quality of life		5 years	No