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

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810614
• Other study ID #: 13493
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: August 11, 2015
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Other:
• ADPKD Diet
Diet specifically designed for people with ADPKD

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADPKD diet impact on net acid excretion	The difference in net acid excretion from a participants regular diet and the ADPKD diet	Change from Baseline to Day 36	No
Secondary	Acceptance of ADPKD diet	Ease with which diet will be embraced by participants	36 days	No
Secondary	Kidney injury markers	Change in urine markers of renal injury in participants	Change from Baseline to Day 36	No