Very Low Protein Diet or Dialysis in Uremic Elderly?

NCT00388648 | Completed Phase 4

• 1 other identifier: NBs2000
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

There are no solid data on the real advantage of an early start of dialysis, as suggested by the DOQI guidelines. Uremic patients frequently have a poor nutritional status. However, we cannot distinguish between the detrimental effect on nutrition of too low a residual renal function or too long a period of low protein-diet, per se. However, it appears that a very-low-protein diet (VLPD) supplemented with essential amino acids and keto-analogs of amino acids, and with an adequate quantity of calories, can prevent hypoalbuminemia at the start of dialysis and can slow the progression of chronic renal failure. EDTA and USRDS data suggest that most patients starting dialysis nowadays are elderly, who also have the highest incidence of morbidity and mortality. Moreover, hospitalization rate becomes higher after the start of dialysis compared to the pre-dialysis period. Can an aminoacid-supplemented VLPD, prolonged beyond the GFR limits suggested by DOQI, offer elderly patients better survival and better quality of life than dialysis? The answer can only come from a prospective, randomized trial, in elderly patients, starting at the GFR values suggested by the NKF-DOQI for starting dialysis, comparing outcomes with a vegetarian VLPD supplemented with a mixture of keto-analogs of amino acids and essential amino acids, and with dialysis.

Conditions

Uremia; Elderly (Aged >70); Dialysis; Low Protein Diet; Survival

Keywords

Dialysis; Vegan Diet; Mortality; Morbidity; Treatment outcome

Outcome Measures

Primary Outcomes (3)

• The primary hypotheses to be tested are whether, at least in the elderly:

• the supplemented Very Low Protein Diet (VLPD) does not increase the risk of morbidity and mortality,

• a prolonged period of VLPD can postpone the need for dialysis in elderly patients, and dialysis can start at a RRF lower than usually suggested.

Secondary Outcomes (1)

• the VLPD does not induce malnutrition.

Interventions

mixture of amino and keto acids DRUG

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• males or females \>= 70 years of age
• RRF 5-7 ml/min/1.73 m2
• left ventricular ejection fraction \>40%
• signed informed written consent

You may not qualify if:

• diabetes
• severe cerebral disease
• proteinuria \>3 g/24 h
• severe hepatic failure
• active malignancy
• COPD requiring supplementary oxygen
• AIDS, or HIV-positive

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

Dept of Nephrology

Brescia, Brescia, 25123, Italy

Location

Related Publications (2)

• Maiorca R, Brunori G, Viola BF, Zubani R, Cancarini G, Parrinello G, De Carli A. Diet or dialysis in the elderly? The DODE study: a prospective randomized multicenter trial. J Nephrol. 2000 Jul-Aug;13(4):267-70.

  PMID: 10946805 RESULT

• Brunori G, Viola BF, Parrinello G, De Biase V, Como G, Franco V, Garibotto G, Zubani R, Cancarini GC. Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study. Am J Kidney Dis. 2007 May;49(5):569-80. doi: 10.1053/j.ajkd.2007.02.278.

  PMID: 17472838 DERIVED

MeSH Terms

Conditions

Uremia

Interventions

Keto Acids

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals

Study Officials

• Giovanni c Cancarini, Prof

  University of Brescia (Italy)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: January 1, 2000
• Study Completion: July 1, 2005
• Last Updated: October 17, 2006

Record last verified: 2006-10

Locations

IT (1)