RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-06
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06210009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Self-reported, documented, and/or prior imaging-based diagnosis of kidney stone disease
  3. * Age 19-89
  4. * Any sex
  5. * Any race
  6. * Able to provide informed consent
  7. * Willing to perform 24-hour urine collections
  8. * Willing to consume meals prepared by Bionutrition Unit
  9. * No food allergies/intolerance to any of the foods in the study menus
  10. * Willing to stop for 7 days before and during study: Multivitamins and/or Dietary supplements (including calcium and vitamin C)
  1. * Dialysis
  2. * Kidney transplant recipient
  3. * Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 based on historical laboratory measurements
  4. * Renal tubular acidosis
  5. * Current use of acetazolamide, topiramate, or zonisamide
  6. * Primary hyperparathyroidism or history of parathyroidectomy
  7. * Hyperthyroidism
  8. * Sarcoidosis
  9. * Primary hyperoxaluria
  10. * Cystinuria
  11. * Nephrotic syndrome
  12. * Malabsorptive conditions including inflammatory bowel disease or history of malabsorptive surgery (e.g., Roux-en-Y gastric bypass, small bowel resection)
  13. * Urinary retention requiring catheterization
  14. * Urinary diversion
  15. * Pregnancy
  16. * Breastfeeding
  17. * Malignancy treated in the past 12 months other than non-melanoma skin cancer

Contacts and Locations

Study Contact

Joseph Crivelli, MD
CONTACT
205-996-8765
crivelli@uab.edu

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-06
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2025-01-06
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • DASH diet
  • Western diet

Additional Relevant MeSH Terms

  • Kidney Stone