Completed

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

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What is being tested

ADPKD Diet

Other
Who is being recruted

Congenital Abnormalities+11

+ Abnormalities, Multiple

+ Ciliopathies

From 18 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of Kansas
Last updated: August 13, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01810614
Principal SponsorUniversity of Kansas
Last updated: August 13, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesAbnormalities, MultipleCiliopathiesUrogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPolycystic Kidney DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrologic DiseasesGenetic Diseases, InbornKidney Diseases, CysticFemale Urogenital DiseasesMale Urogenital DiseasesKidney DiseasesPolycystic Kidney, Autosomal Dominant

Criteria

4 inclusion criteria required to participate
Blood pressure < 135/85 mmHg with or without specific treatment
Diet history consistent with the excretion of > 30 mEq NAE / day based on usual dietary intake
Have not been prescribed dietary restrictions or enhancements
Willingness to participate for at least one month
6 exclusion criteria prevent from participating
Confounding medications, i.e. bicarbonate, citrate
Food allergies
Individuals who do not consume meat for personal, religious, or health reasons
Other active diseases requiring pharmacologic agents
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Kansas Medical Center

Kansas City, United StatesOpen University of Kansas Medical Center in Google Maps
CompletedOne Study Center