Kidney StoneNCT06210009
Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease
A study testing DASH-Style Diet and Western-Style Diet in people with Kidney Stone, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 89 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- DASH-Style Diet and Western-Style Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Joseph Crivelli, MD, 205-996-8765, crivelli@uab.edu
About this study
Official title: Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease: A Randomized Controlled Trial (CARDIA Ancillary Study)
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
- Kidney Stone
- Being tested
- DASH-Style Diet, Western-Style Diet
- Keywords
- DASH diet, Western diet
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH-Style DietOther
Participants will be randomized to a DASH-style diet
Western-Style DietOther
Participants will be randomized to a Western-style diet
| Study group | Role | What they receive |
|---|---|---|
| DASH-Style Diet | Experimental | For seven days, participants will consume a diet characterized by higher intake of fruits, vegetables, and low-fat dairy, in addition to whole grains, poultry, fish, and nuts, but smaller amounts of red meat, sweets, and sugar-containing beverages. Receives: Other: DASH-Style Diet |
| Western-Style Diet | Other | For seven days, participants will consume a diet characterized by characterized by higher intake of red meat, sweets, and items containing added sugar, processed starches, and seed oils, in addition to lower intake of fruits, vegetables, and low-fat dairy. Receives: Other: Western-Style Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the two arms in supersaturation of calcium oxalate
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.
Measured: Days 6-7 of the assigned intervention
Secondary outcomes (9)
Difference between the two arms in supersaturation of calcium oxalate between the baseline and intervention periods
This secondary outcome will be calculated using a difference in differences approach.
Measured: Days 6-7 of the assigned intervention
Difference between the two arms in supersaturation of uric acid
Supersaturation of uric acid is an index reflecting the propensity for the formation and growth of uric acid stones.
Measured: Days 6-7 of the assigned intervention
Difference between the two arms in supersaturation of calcium phosphate
Supersaturation of calcium phosphate is an index reflecting the propensity for the formation and growth of calcium phosphate stones.
Measured: Days 6-7 of the assigned intervention
Difference between the two arms in urine volume
Low urine volume is a stone risk factor.
Measured: Days 6-7 of the assigned intervention
Difference between the two arms in urine calcium
High urine calcium is a stone risk factor.
Measured: Days 6-7 of the assigned intervention
Difference between the two arms in urine oxalate
High urine oxalate is a stone risk factor.
Measured: Days 6-7 of the assigned intervention
Difference between the two arms in urine citrate
Low urine citrate is a stone risk factor.
Measured: Days 6-7 of the assigned intervention
Difference between the two arms in urine uric acid
High urine uric acid is a stone risk factor.
Measured: Days 6-7 of the assigned intervention
Difference between the two arms in urine pH
Urine pH can influence stone formation and growth.
Measured: Days 6-7 of the assigned intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start6 Jan 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Crivelli, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210009
- Sponsor's protocol ID
- IRB-300012217
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease: A Randomized Controlled Trial (CARDIA Ancillary Study)
- ClinicalTrials.gov ID
- NCT06210009
- Acronym / sponsor ID
- IRB-300012217
- Conditions
- Kidney Stone
- Keywords
- DASH diet, Western diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH-Style Diet | Experimental | Other: DASH-Style DietFor seven days, participants will consume a diet characterized by higher intake of fruits, vegetables, and low-fat dairy, in addition to whole grains, poultry, fish, and nuts, but smaller amounts of red meat, sweets, and sugar-containing beverages. |
| Western-Style Diet | Other | Other: Western-Style DietFor seven days, participants will consume a diet characterized by characterized by higher intake of red meat, sweets, and items containing added sugar, processed starches, and seed oils, in addition to lower intake of fruits, vegetables, and low-fat dairy. |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH-Style DietParticipants will be randomized to a DASH-style diet | Other | DASH-Style Diet |
| Western-Style DietParticipants will be randomized to a Western-style diet | Other | Western-Style Diet |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH-Style Diet and Western-Style Diet in people with Kidney Stone, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Crivelli, MD (205-996-8765, crivelli@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the two arms in supersaturation of calcium oxalate (time frame: Days 6-7 of the assigned intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.