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A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)
This study has been completed.
Sponsor:
University of Kansas
Information provided by (Responsible Party):
University of Kansas Medical Center ( University of Kansas )
ClinicalTrials.gov Identifier:
NCT01810614
First received: March 11, 2013
Last updated: August 11, 2015
Last verified: August 2015
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Purpose
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 | Intervention |
|---|---|
| Autosomal Dominant Polycystic Kidney Disease | Other: ADPKD Diet |
| Study Type: | Interventional |
| Study Design: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
polycystic kidney disease
MedlinePlus related topics:
Kidney Diseases
U.S. FDA Resources
Further study details as provided by University of Kansas Medical Center ( University of Kansas ):
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
| Enrollment: | 12 |
| Study Start Date: | February 2013 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: ADPKD Diet
Diet specifically designed for people with ADPKD
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810614
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810614
Locations
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
Sponsors and Collaborators
University of Kansas
Investigators
| Principal Investigator: | Debra Sullivan, PhD, RD | University of Kansas Medical Center |
More Information
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 |
| Study First Received: | March 11, 2013 |
| Last Updated: | August 11, 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 |
ClinicalTrials.gov processed this record on August 17, 2017