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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Kansas Medical Center ( University of Kansas )

ClinicalTrials.gov Identifier:

NCT01810614

First received: March 11, 2013

Last updated: August 11, 2015

Last verified: August 2015

History of Changes

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:

Genetics Home Reference related topics: polycystic kidney disease

MedlinePlus related topics: Kidney Diseases

U.S. FDA Resources

Further study details as provided by University of Kansas Medical Center:

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


Enrollment:	12
Study Start Date:	February 2013
Study Completion Date:	November 2014
Primary Completion Date:	November 2014 (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 (Adult)
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

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: 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:	Debra Sullivan, PhD, RD	University of Kansas Medical Center

More Information


Responsible Party:	University of Kansas
ClinicalTrials.gov Identifier:	NCT01810614 History of Changes
Other Study ID Numbers:	13493
Study First Received:	March 11, 2013
Last Updated:	August 11, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:


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 September 30, 2016

To Top