RECRUITING

Oxalate Formation From Ascorbic Acid

Talk to us

Conditions

Kidney StoneOxalateCalcium oxalate stonesAscorbic Acid

Quick Navigation

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 purpose of this basic research study is to determine the contribution of endogenous ascorbic acid (AA) turnover to urinary oxalate excretion in both normal BMI and obese adult non-stone formers and calcium oxalate stone formers. The studies proposed will use diets of known nutrient composition, a stable isotope of ascorbic acid (13C6-AA) and mass spectrometric techniques to quantify ascorbic acid turnover to oxalate.

Official Title

Oxalate Formation From Ascorbic Acid

Quick Facts

Study Start:2021-11-15
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04603898

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide informed consent
  2. * For stone formers: composition of most recent stone \> 50% calcium oxalate, no uric acid component
  3. * For stone formers: first time or recurrent calcium oxalate stone former with stone event within the prior 3 years
  4. * Two 24-hour urine collections with urinary 24-hour creatinine excretion within 20% of appropriate ratio of creatinine (mg) / body weigh (kg) for gender
  5. * Willingness to stop supplements (vitamins, Calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during study
  6. * Willingness to not undertake vigorous exercise during the study
  7. * Normal fasting blood Comprehensive Metabolic Panel (CMP)
  8. * Willingness to ingest menus prepared in Clinical Research Unit at University of Alabama at Birmingham
  9. * No food allergies or intolerance to any of the foods in study menus
  10. * If on medications for stone prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), they should have been on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during study protocol. If on allopurinol for stone prevention, stop it for 2 weeks prior to screening and this will not be administered during the study as it has anti-oxidant properties.
  1. * Diabetes
  2. * Gout
  3. * Hypertension
  4. * Estimated Glomerular Filtration Rate (eGFR) less than 60ml/min/1.73m2
  5. * Primary hyperoxaluria
  6. * Nephrotic syndrome
  7. * Enteric hyperoxaluria
  8. * Renal tubular acidosis
  9. * Primary hyperparathyroidism
  10. * Liver disease
  11. * Auto-immune disorder
  12. * Neurogenic bladder
  13. * Urinary diversion
  14. * Bariatric surgery
  15. * Active malignancy or treatment for malignancy within 12 months prior to screening
  16. * Pregnancy
  17. * Breastfeeding/nursing individuals
  18. * Females of child bearing age who are not able to use an effective method of birth control during the study
  19. * Mental/medical condition that is likely to impede successful study completion
  20. * Illness including flu/common cold/fever 14 days before study and during study
  21. * Diarrhea or other abnormal gastrointestinal event (e.g. abnormal bowel movements) 14 days before study or during study
  22. * Abnormal fasting CMP

Contacts and Locations

Study Contact

Demond Wiley
CONTACT
2059343671
kidneystone@uabmc.edu

Principal Investigator

John Knight, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35243-3353
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • John Knight, PhD, PRINCIPAL_INVESTIGATOR, 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 Date2021-11-15
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-11-15
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Oxalate
  • Calcium oxalate stones
  • Ascorbic Acid

Additional Relevant MeSH Terms

  • Kidney Stone