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Vitamin
Vitamin C's Impact on Kidney Stones
N/A
Recruiting
Led By John Knight, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For stone formers: first time or recurrent calcium oxalate stone former with stone event within the prior 3 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4
Awards & highlights
Study Summary
This trial will study how much ascorbic acid (AA) the body produces and how it affects the amount of oxalate in urine.
Who is the study for?
This trial is for adults with normal BMI or obese, non-stone formers and calcium oxalate stone formers who haven't had certain health conditions like diabetes, hypertension, or severe kidney issues. Participants must not be on specific medications that could affect the study results and should agree to follow a controlled diet without supplements or vigorous exercise during the study.Check my eligibility
What is being tested?
The study aims to understand how much vitamin C (ascorbic acid) from our diet turns into oxalate in the urine, which can contribute to kidney stones. It involves following a special low-oxalate diet and taking a stable isotope of ascorbic acid orally while researchers measure its turnover using advanced techniques.See study design
What are the potential side effects?
Since this trial involves dietary changes and monitoring rather than drug testing, side effects are minimal but may include discomfort from dietary restrictions or reactions related to consuming the carbon-13 ascorbic acid.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a calcium oxalate kidney stone in the last 3 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent contribution of ascorbic acid (AA) to urinary oxalate excretion
Trial Design
1Treatment groups
Experimental Treatment
Group I: Controlled Dietary StudyExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,346 Total Patients Enrolled
14 Trials studying Kidney Stones
699 Patients Enrolled for Kidney Stones
John Knight, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
23 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidney function is too low (eGFR less than 60ml/min/1.73m2).I have been diagnosed with primary hyperoxaluria.I have high blood pressure.I have been diagnosed with renal tubular acidosis.I have been diagnosed with primary hyperparathyroidism.I have a condition where my bladder doesn't empty properly due to nerve problems.I have high oxalate levels in my urine due to intestinal issues.I have not had cancer or cancer treatment in the last year.I have gout.I have not had the flu, a cold, or fever in the last 14 days.I have nephrotic syndrome.Your fasting blood test results are normal for a comprehensive metabolic panel (CMP).My kidney function tests from urine samples are within the normal range for my gender.I have diabetes.I have a liver condition.I am willing to stop taking supplements for 2 weeks before and during the study.Your blood test results show abnormal levels when you haven't eaten for a while.I have had a calcium oxalate kidney stone in the last 3 years.I cannot use birth control methods effectively during the study.You have a urinary diversion procedure.I've been on a stable dose of stone prevention medication for at least 8 weeks and can stop allopurinol 2 weeks before screening.I have had weight loss surgery.You have an autoimmune disease.I have not had diarrhea or unusual bowel movements in the last 14 days.If you have a history of making kidney stones, the most recent stone you made was mostly made of calcium oxalate and did not have any uric acid in it.
Research Study Groups:
This trial has the following groups:- Group 1: Controlled Dietary Study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are senior citizens eligible to participate in this trial?
"Based on the prerequisites for this study, individuals must be between 19 and 75 to qualify for enrollment."
Answered by AI
Could I be considered a candidate for this experiment?
"Eligibility criteria for this clinical trial entails having kidney stones and being between 19-75 years of age. Participation is limited to 136 individuals in total."
Answered by AI
Are there still opportunities for individuals to join this research program?
"Per the information published on clinicaltrials.gov, this specific trial is presently looking for participants and was initially posted to the website in November 2021 with its last amendment taking place a year later."
Answered by AI
How many participants have been recruited to participate in this medical experiment?
"Affirmative. Clinicaltrials.gov reflects that this clinical experiment, originally uploaded on November 15th 2021, is still recruiting subjects. A total of 136 people must be enrolled at 1 medical centre."
Answered by AI
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