NCT06210009 Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease
| NCT ID | NCT06210009 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-01-06 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06210009 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 89 Years, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06210009 currently recruiting?
Yes, NCT06210009 is actively recruiting participants. Contact the research team at crivelli@uab.edu for enrollment information.
Where is the NCT06210009 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06210009 clinical trial?
NCT06210009 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 48 participants.
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