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

This study is currently recruiting participants.
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

August 10, 2011
January 28, 2013
August 2011
August 2016   (final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 5-years (60 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01415570 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD)
Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD) - A Prospective Data Collection Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Probability Sample

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

  • Chronic Kidney Disease (CKD)
  • End-Stage Renal Disease (ESRD)
Not Provided
  • Chronic Hemodialysis Patients
    Adult hemodialysis patients
  • Chronic hemodialysis patients
    Adult hemodialysis patients

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1050
November 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Terminal disease with life expectancy < 6 months
Both
18 Years to 85 Years
No
Contact: Caludia Luna 310-222-2346 cluna@labiomed.org
Contact: Jennie Jing, MS 310-781-3650 jjing@labiomed.org
United States
 
NCT01415570
14100, K24DK091419
No
Los Angeles Biomedical Research Institute
Los Angeles Biomedical Research Institute
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Harold Simmons Center for Kidney Disease Research & Epidemiology (HSC-KDRE)
  • Davita Clinical Research
Principal Investigator: Kamyar Kalantar-Zadeh, MD, MPH, PhD LABioMed at Harbor-UCLA
Los Angeles Biomedical Research Institute
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP