Trial Outcomes & Findings for Dietary Oxalate and Innate Immunity in Kidney Stone Disease (NCT NCT04051346)
NCT ID: NCT04051346
Last Updated: 2026-06-26
Results Overview
Twenty-four hour urinary oxalate will be reported as mg/day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Days 4 and 14
Results posted on
2026-06-26
Participant Flow
Participant milestones
| Measure |
Low Oxalate Diet
Subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the high oxalate diet for the final four days, with blood and 24-hour urine collections once again post diet.
Low Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
High Oxalate Diet
Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the low oxalate diet for the final four days, with blood and 24-hour urine collections once again post diet.
High Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
|---|---|---|
|
Phase I - 4 days
STARTED
|
7
|
7
|
|
Phase I - 4 days
COMPLETED
|
7
|
7
|
|
Phase I - 4 days
NOT COMPLETED
|
0
|
0
|
|
Washout - 10 Day
STARTED
|
7
|
7
|
|
Washout - 10 Day
COMPLETED
|
7
|
7
|
|
Washout - 10 Day
NOT COMPLETED
|
0
|
0
|
|
Phase II - 4 days
STARTED
|
7
|
7
|
|
Phase II - 4 days
COMPLETED
|
7
|
7
|
|
Phase II - 4 days
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dietary Oxalate and Innate Immunity in Kidney Stone Disease
Baseline characteristics by cohort
| Measure |
All Study Participants
n=14 Participants
All Participants were included in the Crossover of both Low Oxalate Diet and High Oxalate Diet.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 13.6 • n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Days 4 and 14Twenty-four hour urinary oxalate will be reported as mg/day.
Outcome measures
| Measure |
Low Oxalate Diet
n=14 Participants
Subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the high oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.
Low Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
High Oxalate Diet
n=14 Participants
Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the low oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.
High Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
|---|---|---|
|
Urinary Oxalate Excretion
|
8.59 mg/day
Standard Error 1
|
13.97 mg/day
Standard Error 2.38
|
PRIMARY outcome
Timeframe: Day 4 and 14Crystalluria will be reported as particles/ml.
Outcome measures
| Measure |
Low Oxalate Diet
n=14 Participants
Subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the high oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.
Low Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
High Oxalate Diet
n=14 Participants
Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the low oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.
High Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
|---|---|---|
|
Crystalluria
|
816,000,000 particles/ml
Standard Error 90,000,000
|
850,000,000 particles/ml
Standard Error 96,200,000
|
PRIMARY outcome
Timeframe: Days 4 and 14Cellular energetic oxygen consumption traces will be examined.
Outcome measures
| Measure |
Low Oxalate Diet
n=14 Participants
Subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the high oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.
Low Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
High Oxalate Diet
n=14 Participants
Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the low oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.
High Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
|---|---|---|
|
Number of Participants With Monocyte Cellular Energetics
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Days 4 and 14Monocyte cellular transcriptomics will be determined using RNA sequencing (mRNA).
Outcome measures
| Measure |
Low Oxalate Diet
n=14 Participants
Subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the high oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.
Low Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
High Oxalate Diet
n=14 Participants
Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the low oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.
High Oxalate Diet: 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, to exercise strenuously, or to consume food or drink that is not provided to them.
|
|---|---|---|
|
Number of Participants With Monocyte Transcriptomics
|
14 Participants
|
14 Participants
|
Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place