NCT01810614

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

March 11, 2013

Last Update Submit

August 11, 2015

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

ADPKDPKDKidney DiseaseADPKD diet

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Acceptance of ADPKD diet

    36 days

  • Kidney injury markers

    Change from Baseline to Day 36

Study Arms (1)

ADPKD Diet

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.

Other: ADPKD Diet

Interventions

ADPKD DietOTHER

Diet specifically designed for people with ADPKD

ADPKD Diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • Taylor JM, Ptomey L, Hamilton-Reeves JM, Sullivan DK, Creed C, Carlson SE, Wesson DE, Grantham JJ, Gibson CA. Experiences and Perspectives of Polycystic Kidney Disease Patients following a Diet of Reduced Osmoles, Protein, and Acid Precursors Supplemented with Water: A Qualitative Study. PLoS One. 2016 Aug 18;11(8):e0161043. doi: 10.1371/journal.pone.0161043. eCollection 2016.

    PMID: 27537328DERIVED

  • Taylor JM, Hamilton-Reeves JM, Sullivan DK, Gibson CA, Creed C, Carlson SE, Wesson DE, Grantham JJ. Diet and polycystic kidney disease: A pilot intervention study. Clin Nutr. 2017 Apr;36(2):458-466. doi: 10.1016/j.clnu.2016.01.003. Epub 2016 Jan 11.

    PMID: 26811129DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantKidney Diseases

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Officials

  • Debra Sullivan, PhD, RD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 13, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

US(1)