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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01415570
Recruitment Status : Unknown
Verified May 2015 by Los Angeles Biomedical Research Institute.
Recruitment status was:  Recruiting
First Posted : August 12, 2011
Last Update Posted : May 21, 2015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Davita Clinical Research
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute

Brief 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.

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

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.

Study Type : Observational
Estimated Enrollment : 1050 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition, Diet and Racial Disparities in Chronic Kidney Disease (CKD) - A Prospective Data Collection Study
Study Start Date : August 2011
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Chronic Hemodialysis Patients
Adult hemodialysis patients
Chronic hemodialysis patients
Adult hemodialysis patients

Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 5-years (60 months) ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult (18-85 yrs) patients, hemodialysis (HD) > 4 weeks

Inclusion Criteria:

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

Exclusion Criteria:

  • Terminal disease with life expectancy < 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01415570

Contact: Caludia Luna 310-222-2346
Contact: Jennie Jing, MS 310-781-3650

United States, California
Harold Simmons Center for Kidney Disease Research & Epidemiology Recruiting
Torrance, California, United States, 90502
Contact: Claudia Luna    310-222-2346   
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Davita Clinical Research
Principal Investigator: Kamyar Kalantar-Zadeh, MD, MPH, PhD LABioMed at Harbor-UCLA


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Los Angeles Biomedical Research Institute Identifier: NCT01415570     History of Changes
Other Study ID Numbers: 14100
K24DK091419 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

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

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