Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk
Primary Purpose
Hyperoxaluria
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aloe vera with cactus
Cranberry
Green tea extract
Bilberry
Cinnamon
Milk thistle
Turmeric
Aloe vera
Sponsored by
About this trial
This is an interventional basic science trial for Hyperoxaluria
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age, no prior personal history of kidney stones
Exclusion Criteria:
- Personal history of kidney stones (by subjects' report); known allergy to any of the dietary supplements to be used in the study (by subjects' report); short bowel; active ulcerative colitis or irritable bowel disease; Crohns or Celiac disease; renal tubular acidosis; current use of topiramate or other carbonic anhydrase inhibitor, steroids, allopurinol, thiazide diuretics, or supplemental ascorbic acid >250 mg/day.
Sites / Locations
- Department of Urology, School of Medicine & Public Health, University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Aloe vera with cactus
Cranberry
Green tea extract
Bilberry
Cinnamon
Milk thistle
Turmeric
Aloe vera
Arm Description
1 capsule (500 mg), 2 times/day
3 capsules (810 mg), 2 times/day
2 capsules (630 mg), 2 times/day
1 softgel (1000 mg), 2 times/day
1 capsule (500 mg), 2 times/day
1 capsule (250 mg), 3 times/day
1 capsule (450 mg turmeric + 50 mg turmeric extract), 1 time/day
1 capsule (470 mg), 2 times/day
Outcomes
Primary Outcome Measures
Within-subject change in 24-hour urinary oxalate excretion from before and after supplementation
24-hour urine samples will be analyzed for oxalate by ion chromatography. The difference in oxalate between the baseline (non-supplement) and supplement phase will be assessed.
Secondary Outcome Measures
Full Information
NCT ID
NCT02404701
First Posted
March 26, 2015
Last Updated
October 26, 2016
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT02404701
Brief Title
Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk
Official Title
Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to ascertain whether certain supplements promote excessive urinary oxalate excretion and increase the risk for calcium oxalate kidney stones. Supplements that enhance urinary oxalate excretion, as a result of their oxalate concentration or from some other mechanism (e.g., providing substrate for oxalate biosynthesis) will be identified by the investigators.
Detailed Description
The investigators hypothesize that certain over-the-counter dietary supplements will increase urinary excretion of oxalate as measured in 24-h urine collections. The investigators further hypothesize that the concentration of oxalate in dietary supplements may not be associated with urinary oxalate excretion, suggesting that other nutritional components of the supplements may be exerting an influence over oxalate biosynthesis, oxalate absorption in the gastrointestinal tract, and/or renal oxalate handling. These other factors include the form of oxalate in the supplement (water- vs. non water-soluble) and the supplement's concentration of ascorbic acid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxaluria
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aloe vera with cactus
Arm Type
Experimental
Arm Description
1 capsule (500 mg), 2 times/day
Arm Title
Cranberry
Arm Type
Experimental
Arm Description
3 capsules (810 mg), 2 times/day
Arm Title
Green tea extract
Arm Type
Experimental
Arm Description
2 capsules (630 mg), 2 times/day
Arm Title
Bilberry
Arm Type
Experimental
Arm Description
1 softgel (1000 mg), 2 times/day
Arm Title
Cinnamon
Arm Type
Experimental
Arm Description
1 capsule (500 mg), 2 times/day
Arm Title
Milk thistle
Arm Type
Experimental
Arm Description
1 capsule (250 mg), 3 times/day
Arm Title
Turmeric
Arm Type
Experimental
Arm Description
1 capsule (450 mg turmeric + 50 mg turmeric extract), 1 time/day
Arm Title
Aloe vera
Arm Type
Experimental
Arm Description
1 capsule (470 mg), 2 times/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Aloe vera with cactus
Other Intervention Name(s)
Walgreens
Intervention Description
Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry
Other Intervention Name(s)
Puritan's Pride
Intervention Description
Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea extract
Other Intervention Name(s)
Puritan's Pride
Intervention Description
Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bilberry
Other Intervention Name(s)
Puritan's Pride
Intervention Description
Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cinnamon
Other Intervention Name(s)
Puritan's Pride
Intervention Description
Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk thistle
Other Intervention Name(s)
Puritan's Pride
Intervention Description
Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric
Other Intervention Name(s)
Puritan's Pride
Intervention Description
Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
Intervention Type
Dietary Supplement
Intervention Name(s)
Aloe vera
Other Intervention Name(s)
Puritan's Pride
Intervention Description
Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
Primary Outcome Measure Information:
Title
Within-subject change in 24-hour urinary oxalate excretion from before and after supplementation
Description
24-hour urine samples will be analyzed for oxalate by ion chromatography. The difference in oxalate between the baseline (non-supplement) and supplement phase will be assessed.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age, no prior personal history of kidney stones
Exclusion Criteria:
Personal history of kidney stones (by subjects' report); known allergy to any of the dietary supplements to be used in the study (by subjects' report); short bowel; active ulcerative colitis or irritable bowel disease; Crohns or Celiac disease; renal tubular acidosis; current use of topiramate or other carbonic anhydrase inhibitor, steroids, allopurinol, thiazide diuretics, or supplemental ascorbic acid >250 mg/day.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina L Penniston, PhD, RD
Organizational Affiliation
Department of Urology, University of Wisconsin School of Medicine and Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, School of Medicine & Public Health, University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2281
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk
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