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NCT Number: NCT01810614

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

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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ADPKD Diet

Other

Diet specifically designed for people with ADPKD

Primary outcomes

  1. ADPKD diet impact on net acid excretion

    Time frame: Change from Baseline to Day 36

    The difference in net acid excretion from a participants regular diet and the ADPKD diet

Secondary outcomes

  1. Acceptance of ADPKD diet

    Time frame: 36 days

    Ease with which diet will be embraced by participants

  2. Kidney injury markers

    Time frame: Change from Baseline to Day 36

    Change in urine markers of renal injury in participants

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2013
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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