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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Los Angeles Biomedical Research Institute
Sponsor:
Collaborators:
Harold Simmons Center for Kidney Disease Research & Epidemiology (HSC-KDRE)
Davita Clinical Research
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01415570
First received: August 10, 2011
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition
Chronic Kidney Disease (CKD)
End-Stage Renal Disease (ESRD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD) - A Prospective Data Collection Study

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 5-years (60 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 1050
Study Start Date: August 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Hemodialysis Patients
Adult hemodialysis patients
Chronic hemodialysis patients
Adult hemodialysis patients

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult (18-85 yrs) patients, hemodialysis (HD) > 4 weeks

Criteria

Inclusion Criteria:

  • Adult (18-85 yrs) patients
  • HD > 4 weeks

Exclusion Criteria:

  • Terminal disease with life expectancy < 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415570

Contacts
Contact: Caludia Luna 310-222-2346 cluna@labiomed.org
Contact: Jennie Jing, MS 310-781-3650 jjing@labiomed.org

Locations
United States, California
Harold Simmons Center for Kidney Disease Research & Epidemiology Recruiting
Torrance, California, United States, 90502
Contact: Claudia Luna    310-222-2346    cluna@labiomed.org   
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Harold Simmons Center for Kidney Disease Research & Epidemiology (HSC-KDRE)
Davita Clinical Research
Investigators
Principal Investigator: Kamyar Kalantar-Zadeh, MD, MPH, PhD LABioMed at Harbor-UCLA
  More Information

Publications:

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01415570     History of Changes
Other Study ID Numbers: 14100, K24DK091419
Study First Received: August 10, 2011
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Los Angeles Biomedical Research Institute:
Protein-energy wasting (PEW)
racial disparities
hemodialysis
survival paradoxes
Stage 5

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Malnutrition
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Nutrition Disorders

ClinicalTrials.gov processed this record on July 22, 2014