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

Kidney Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210009
• Other study ID #: IRB-300012217
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Joseph Crivelli, MD
• Phone: 205-996-8765
• Email: crivelli[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Birmingham, Alabama area participants of the Coronary Artery Risk Development in Young Adults (CARDIA) study or patients of the University of Alabama at Birmingham

• Self-reported history of kidney stone disease

• Able to provide informed consent

• Willing to consume meals prepared by Bionutrition Unit

• No food allergies/intolerance to any of the foods in the study menus

• Willing to stop dietary supplements including calcium and vitamin C for 14 days before and during study

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

• Hyperthyroidism

• Sarcoidosis

• Primary hyperoxaluria

• Cystinuria

• Nephrotic syndrome

• Malabsorptive conditions including inflammatory bowel disease and history of gastric bypass

• Urinary retention requiring catheterization

• Urinary diversion

• Pregnancy

• Breastfeeding

• Malignancy treated in the past 12 months other than non-melanoma skin cancer

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Days 6-7 of the assigned intervention
Secondary	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.	Days 6-7 of the assigned intervention
Secondary	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.	Days 6-7 of the assigned intervention
Secondary	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.	Days 6-7 of the assigned intervention
Secondary	Difference between the two arms in urine volume	Low urine volume is a stone risk factor.	Days 6-7 of the assigned intervention
Secondary	Difference between the two arms in urine calcium	High urine calcium is a stone risk factor.	Days 6-7 of the assigned intervention
Secondary	Difference between the two arms in urine oxalate	High urine oxalate is a stone risk factor.	Days 6-7 of the assigned intervention
Secondary	Difference between the two arms in urine citrate	Low urine citrate is a stone risk factor.	Days 6-7 of the assigned intervention
Secondary	Difference between the two arms in urine uric acid	High urine uric acid is a stone risk factor.	Days 6-7 of the assigned intervention
Secondary	Difference between the two arms in urine pH	Urine pH can influence stone formation and growth.	Days 6-7 of the assigned intervention