Menu
Recruiting NCT06210009

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

No phase Interventional Kidney Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DASH-Style Diet, Western-Style Diet.
Who it may be relevant to
Registry conditions: Kidney Stone. Basic parameters: 19 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease: A Randomized Controlled Trial (CARDIA Ancillary Study)

Overview

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.

Interventions

  • Other DASH-Style Diet
    Participants will be randomized to a DASH-style diet
  • Other Western-Style Diet
    Participants will be randomized to a Western-style diet

Primary outcome measures

  • Difference between the two arms in supersaturation of calcium oxalate [Time frame: Days 6-7 of the assigned intervention]
Secondary outcome measures (9)
  • Difference between the two arms in supersaturation of calcium oxalate between the baseline and intervention periods [Time frame: Days 6-7 of the assigned intervention]
  • Difference between the two arms in supersaturation of uric acid [Time frame: Days 6-7 of the assigned intervention]
  • Difference between the two arms in supersaturation of calcium phosphate [Time frame: Days 6-7 of the assigned intervention]
  • Difference between the two arms in urine volume [Time frame: Days 6-7 of the assigned intervention]
  • Difference between the two arms in urine calcium [Time frame: Days 6-7 of the assigned intervention]
  • Difference between the two arms in urine oxalate [Time frame: Days 6-7 of the assigned intervention]
  • Difference between the two arms in urine citrate [Time frame: Days 6-7 of the assigned intervention]
  • Difference between the two arms in urine uric acid [Time frame: Days 6-7 of the assigned intervention]
  • Difference between the two arms in urine pH [Time frame: Days 6-7 of the assigned intervention]

Eligibility criteria

Inclusion criteria

  • Birmingham, AL area participants of the Coronary Artery Risk Development in Young Adults (CARDIA) study OR patients of the University of Alabama at Birmingham/Kirklin Clinic
  • Self-reported, documented, and/or prior imaging-based diagnosis of kidney stone disease
  • Age 19-89
  • Any sex
  • Any race
  • Able to provide informed consent
  • Willing to perform 24-hour urine collections
  • Willing to consume meals prepared by Bionutrition Unit
  • No food allergies/intolerance to any of the foods in the study menus
  • Willing to stop for 7 days before and during study: Multivitamins and/or Dietary supplements (including calcium and vitamin C)

Exclusion criteria

  • Dialysis
  • Kidney transplant recipient
  • Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 based on historical laboratory measurements
  • Renal tubular acidosis
  • Current use of acetazolamide, topiramate, or zonisamide
  • Primary hyperparathyroidism or history of parathyroidectomy
  • Hyperthyroidism
  • Sarcoidosis
  • Primary hyperoxaluria
  • Cystinuria
  • Nephrotic syndrome
  • Malabsorptive conditions including inflammatory bowel disease or history of malabsorptive surgery (e.g., Roux-en-Y gastric bypass, small bowel resection)
  • Urinary retention requiring catheterization
  • Urinary diversion
  • Pregnancy
  • Breastfeeding
  • Malignancy treated in the past 12 months other than non-melanoma skin cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT06210009 · IRB-300012217

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗