A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)
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ClinicalTrials.gov Identifier: NCT01810614 |
Recruitment Status
:
Completed
First Posted
: March 13, 2013
Last Update Posted
: August 13, 2015
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Autosomal Dominant Polycystic Kidney Disease | Other: ADPKD Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD) |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
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.
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Other: ADPKD Diet
Diet specifically designed for people with ADPKD
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- 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
- Acceptance of ADPKD diet [ Time Frame: 36 days ]Ease with which diet will be embraced by participants
- Kidney injury markers [ Time Frame: Change from Baseline to Day 36 ]Change in urine markers of renal injury in participants

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810614
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Debra Sullivan, PhD, RD | University of Kansas Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT01810614 History of Changes |
Other Study ID Numbers: |
13493 |
First Posted: | March 13, 2013 Key Record Dates |
Last Update Posted: | August 13, 2015 |
Last Verified: | August 2015 |
Keywords provided by University of Kansas Medical Center ( University of Kansas ):
ADPKD PKD Kidney Disease ADPKD diet |
Additional relevant MeSH terms:
Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases |
Kidney Diseases, Cystic Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn |