A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Franz Winklhofer, MD, University of Kansas
ClinicalTrials.gov Identifier:
NCT01810614
First received: March 11, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

Recent evidence has shown that kidney volume predicts the likelihood of developing renal insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth of cysts and the harm they do to kidney function. Recent studies indicate that the rate of kidney volume increase is hastened by excess dietary protein, salt, and potential net acid precursors, and slowed by increased water intake sufficient to lower plasma vasopressin levels.

Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the end-stage, but there is currently no specific diet prescription that takes potentially harmful dietary elements into account for ADPKD patients in the earliest stages of the disease. This study will examine a novel diet for ADPKD created by the researcher termed the ADPKD diet.


Condition Intervention
Autosomal Dominant Polycystic Kidney Disease
Other: ADPKD Diet

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • ADPKD diet impact on net acid excretion [ Time Frame: Change from Baseline to Day 36 ] [ Designated as safety issue: No ]
    The difference in net acid excretion from a participants regular diet and the ADPKD diet


Secondary Outcome Measures:
  • Acceptance of ADPKD diet [ Time Frame: 36 days ] [ Designated as safety issue: No ]
    Ease with which diet will be embraced by participants

  • Kidney injury markers [ Time Frame: Change from Baseline to Day 36 ] [ Designated as safety issue: No ]
    Change in urine markers of renal injury in participants


Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADPKD Diet
All study participants will follow their regular diet for 8 days. After that, they will be asked to follow the ADPKD diet for a total of 4 weeks.
Other: ADPKD Diet
Diet specifically designed for people with ADPKD

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have not been prescribed dietary restrictions or enhancements
  • Blood pressure <135/85 mmHg with or without specific treatment
  • Willingness to participate for at least one month
  • Diet history consistent with the excretion of >30 mEq NAE / day based on usual dietary intake

Exclusion Criteria:

  • Other active diseases requiring pharmacologic agents
  • Unstable weight (+/- 2 kg) for 3 months prior to enrollment
  • Food allergies
  • Pregnancy or lactating
  • Confounding medications, i.e. bicarbonate, citrate
  • Individuals who do not consume meat for personal, religious, or health reasons.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810614

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Franz Winklhofer, MD University of Kansas
  More Information

No publications provided

Responsible Party: Franz Winklhofer, MD, Associate Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01810614     History of Changes
Other Study ID Numbers: 13493
Study First Received: March 11, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
ADPKD
PKD
Kidney Disease
ADPKD diet

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on April 16, 2014