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NCT Number: NCT06210009

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

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.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

19 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Joseph Crivelli, MD

CONTACT

[email protected]

205-996-8765

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DASH-Style Diet

Other

Participants will be randomized to a DASH-style diet

Western-Style Diet

Other

Participants will be randomized to a Western-style diet

Primary outcomes

  1. Difference between the two arms in supersaturation of calcium oxalate

    Time frame: Days 6-7 of the assigned intervention

    Supersaturation of calcium oxalate is an index reflecting the propensity for the formation and growth of the most common stone type (calcium oxalate), which is calculated using excretion rates including urinary volume, calcium, citrate, and oxalate.

Secondary outcomes

  1. 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

    This secondary outcome will be calculated using a difference in differences approach.

  2. Difference between the two arms in supersaturation of uric acid

    Time frame: Days 6-7 of the assigned intervention

    Supersaturation of uric acid is an index reflecting the propensity for the formation and growth of uric acid stones.

  3. Difference between the two arms in supersaturation of calcium phosphate

    Time frame: Days 6-7 of the assigned intervention

    Supersaturation of calcium phosphate is an index reflecting the propensity for the formation and growth of calcium phosphate stones.

  4. Difference between the two arms in urine volume

    Time frame: Days 6-7 of the assigned intervention

    Low urine volume is a stone risk factor.

  5. Difference between the two arms in urine calcium

    Time frame: Days 6-7 of the assigned intervention

    High urine calcium is a stone risk factor.

  6. Difference between the two arms in urine oxalate

    Time frame: Days 6-7 of the assigned intervention

    High urine oxalate is a stone risk factor.

  7. Difference between the two arms in urine citrate

    Time frame: Days 6-7 of the assigned intervention

    Low urine citrate is a stone risk factor.

  8. Difference between the two arms in urine uric acid

    Time frame: Days 6-7 of the assigned intervention

    High urine uric acid is a stone risk factor.

  9. Difference between the two arms in urine pH

    Time frame: Days 6-7 of the assigned intervention

    Urine pH can influence stone formation and growth.

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Crivelli, MD

CONTACT

[email protected]

205-996-8765

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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