Health TrialsbyHealthPanel

Oxalate-Driven Host Responses in Kidney Stone Disease

ConditionKidney Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Alabama at Birmingham

About this trial

This study is looking to understand the role of oxalate on kidney stone development and immunity. This study will enroll healthy participants and participants with calcium oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks, consume controlled diets, and provide blood and urine specimens.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men and women between the ages of 18 and 60 years old.

Able to provide informed consent.

BMI between 20-30 kg/m2.

Non-tobacco users or not pregnant/breastfeeding/nursing.

Disqualifiers

Failure to meet the inclusion criteria or physician refusal.

Inability to sign and read the informed consent.

Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements.

BMI ˃30 kg/m2 and <20 kg/m2

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low Oxalate Diet

    Dietary supplement

    Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

  • High Oxalate Diet

    Dietary supplement

    Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Healthy ParticipantsExperimental treatment 2 interventions
Group B: Calcium Oxalate Kidney StoneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Urinary Oxalate

Twenty-four hour urinary oxalate will be reported as mg/day.

Time frame
Days 3-4 and 13-14
2

Change in Nanocystalluria

Nanocrystalluria will be reported as particles/ml.

Time frame
Days 3-4 and 13-14
3

Monocyte Cellular Bioenergetics and Mitochondrial Function

Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

Time frame
Day 1
4

Monocyte Cellular Bioenergetics and Mitochondrial Function

Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

Time frame
Day 4

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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