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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

Must not have

Primary hyperoxaluria

Renal tubular acidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 4

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have had a calcium oxalate kidney stone in the last 3 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with primary hyperoxaluria.

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I have been diagnosed with renal tubular acidosis.

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I have been diagnosed with primary hyperparathyroidism.

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I have a condition where my bladder doesn't empty properly due to nerve problems.

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I have high oxalate levels in my urine due to intestinal issues.

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I have gout.

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I have nephrotic syndrome.

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I have diabetes.

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I cannot use birth control methods effectively during the study.

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I have had weight loss surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent contribution of ascorbic acid (AA) to urinary oxalate excretion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met