Oxalate Formation From Ascorbic Acid

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
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• Able to provide informed consent

• For stone formers: composition of most recent stone \> 50% calcium oxalate, no uric acid component

• For stone formers: first time or recurrent calcium oxalate stone former with stone event within the prior 3 years

• Two 24-hour urine collections with urinary 24-hour creatinine excretion within 20% of appropriate ratio of creatinine (mg) / body weigh (kg) for gender

• 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

• Willingness to not undertake vigorous exercise during the study

• Normal fasting blood Comprehensive Metabolic Panel (CMP)

• Willingness to ingest menus prepared in Clinical Research Unit at University of Alabama at Birmingham

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

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Demond Wiley
kidneystone@uabmc.edu
2059343671
Time Frame
Start Date: 2021-11-15
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 136
Treatments
Experimental: Controlled Dietary Study
Subjects will consume a controlled diet (low in oxalate and ascorbic acid) for six days. After two days of equilibration, subjects will provide a blood sample and ingest an oral load of ascorbic acid (1 mg/kg) with breakfast on Day 3. The following day (Day 4), serial blood and urine collections will occur. On Days 5 through 7, subjects will complete a 24-hr urine collection and blood draw.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov