Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331546
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-19
Brief Title:
Gut Oxalate Absorption in Calcium Oxalate Stone Disease
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Gastrointestinal Oxalate Absorption in Calcium Oxalate Stone Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate which would lead to increased urinary excretion of oxalate
The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones
Participants will
ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time
ingest a soluble form of oxalate and sugar preparations to test gut permeability
collect urine blood stool and breath sample during the fixed diets and the soluble oxalate test
The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones
Participants will
ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time
ingest a soluble form of oxalate and sugar preparations to test gut permeability
collect urine blood stool and breath sample during the fixed diets and the soluble oxalate test
Detailed Description:
In this study the investigators propose to measure the net gastrointestinal absorption of oxalate both by food-bound oxalate using low- 60 mgday and high- 250-300 mgday oxalate diets 600-800 mg daily calcium in both and by the soluble 13C2-oxalate oral test in both Calcium Oxalate Kidney Stone patients and matched controls
Phase 1 Screening and low-oxalate diet 24-hr urinary excretions Between the University of Alabama at Birmingham UAB and the University of Texas Southwestern Medical Center UTSW the study will enroll 40 subjects with idiopathic Calcium Oxalate Kidney Stone 20 Males20 Females and 40 non-kidney stone forming controls 20 Males20 Females Participants in the two groups will be matched for age within 10 yrs and gender Screening will include blood complete metabolic profile and two 24-hr urine specimens collected at home on self-choice diets and anthropometric measurements
Participants will then ingest the controlled low-oxalate 60 mgd diet for 5 consecutive days and collect two 24-hr urines after 2 days of dietary equilibration
Phase 2 13C2-Oxalate gut absorption tests On Day 5 participants will arrive after an overnight fast in the research unit to undergo the 13C2-oxalate absorption test After a 1-hour baseline urine collection they will ingest an oral load containing 100 mg 13C2-oxalate and 1 g sucralose dissolved in bottled water For the next 9 hrs blood and urine will be collected hourly and breath as more time points They will remain on the fixed diet for 24 hrs with a breakfast 2 hours after the load lunch 6 hrs post-load and dinner at home 12 hrs post-load They will collect the remainder of their 24-hr urine at home and the totality of the stool eliminated during the first 24 hrs after the load using kits provided
Phase 3 High-oxalate diet 24-hr urinary excretions After a minimum of 1 week wash-out period during which participants will eat freely participants will consume the high oxalate 250-300 mgday diet for the next 4 days Two 24-hr urine specimens will be collected after 2 days of equilibration and a fasting blood draw on the morning of Day 5
Phase 1 Screening and low-oxalate diet 24-hr urinary excretions Between the University of Alabama at Birmingham UAB and the University of Texas Southwestern Medical Center UTSW the study will enroll 40 subjects with idiopathic Calcium Oxalate Kidney Stone 20 Males20 Females and 40 non-kidney stone forming controls 20 Males20 Females Participants in the two groups will be matched for age within 10 yrs and gender Screening will include blood complete metabolic profile and two 24-hr urine specimens collected at home on self-choice diets and anthropometric measurements
Participants will then ingest the controlled low-oxalate 60 mgd diet for 5 consecutive days and collect two 24-hr urines after 2 days of dietary equilibration
Phase 2 13C2-Oxalate gut absorption tests On Day 5 participants will arrive after an overnight fast in the research unit to undergo the 13C2-oxalate absorption test After a 1-hour baseline urine collection they will ingest an oral load containing 100 mg 13C2-oxalate and 1 g sucralose dissolved in bottled water For the next 9 hrs blood and urine will be collected hourly and breath as more time points They will remain on the fixed diet for 24 hrs with a breakfast 2 hours after the load lunch 6 hrs post-load and dinner at home 12 hrs post-load They will collect the remainder of their 24-hr urine at home and the totality of the stool eliminated during the first 24 hrs after the load using kits provided
Phase 3 High-oxalate diet 24-hr urinary excretions After a minimum of 1 week wash-out period during which participants will eat freely participants will consume the high oxalate 250-300 mgday diet for the next 4 days Two 24-hr urine specimens will be collected after 2 days of equilibration and a fasting blood draw on the morning of Day 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK137784 | NIH | None | httpsreporternihgovquickSearchR01DK137784 |