Actively Recruiting

Phase Not Applicable
Age: 19Years - 89Years
All Genders
NCT06210009

Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease

Led by University of Alabama at Birmingham · Updated on 2026-01-13

48

Participants Needed

1

Research Sites

138 weeks

Total Duration

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AI-Summary

What this Trial Is About

The true capacity for a healthy diet to improve urinary stone risk factors is not well-defined. The objective of this study is to measure the effect of adopting a healthy dietary pattern on kidney stone disease (KSD) risk. The working hypothesis is that a Dietary Approaches to Stop Hypertension (DASH)-style diet will improve 24-hour urine stone risk parameters. The approach to testing this hypothesis will be to randomize participants with KSD to a standardized DASH-style vs. Western-style diet for one week. The Bionutrition Unit of the Center for Clinical and Translational Science will provide all meals to participants. The rationale for this study is that by measuring the effect of a DASH-style diet on urinary stone risk parameters, a benchmark for future real-world, implementation studies will be established. Based on available evidence, this will be the first controlled diet study to assess the DASH dietary pattern for improving urinary stone risk parameters.

CONDITIONS

Official Title

Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease

Who Can Participate

Age: 19Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be from the Birmingham, AL area and part of the CARDIA study or patients at University of Alabama at Birmingham/Kirklin Clinic
  • Have a self-reported, documented, or imaging-confirmed diagnosis of kidney stone disease
  • Be between 19 and 89 years old
  • Any sex and any race
  • Able to provide informed consent
  • Willing to complete 24-hour urine collections
  • Willing to eat all meals prepared by the Bionutrition Unit
  • No allergies or intolerances to foods in the study menus
  • Willing to stop taking multivitamins and dietary supplements, including calcium and vitamin C, for 7 days before and during the study
Not Eligible

You will not qualify if you...

  • Currently on dialysis
  • Received a kidney transplant
  • Have an estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73m2
  • Have renal tubular acidosis
  • Currently take acetazolamide, topiramate, or zonisamide
  • Have primary hyperparathyroidism or a history of parathyroid surgery
  • Have hyperthyroidism
  • Have sarcoidosis
  • Have primary hyperoxaluria
  • Have cystinuria
  • Have nephrotic syndrome
  • Have malabsorptive conditions including inflammatory bowel disease or history of malabsorptive surgery such as gastric bypass or small bowel resection
  • Have urinary retention requiring catheterization
  • Have urinary diversion
  • Are pregnant or breastfeeding
  • Have had cancer treated in the past 12 months except non-melanoma skin cancer

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

J

Joseph Crivelli, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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