Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk

Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk

Sponsors

Lead sponsor: University of Wisconsin, Madison

Source University of Wisconsin, Madison
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.

Overall Status Completed
Start Date February 2015
Completion Date October 2016
Primary Completion Date October 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Within-subject change in 24-hour urinary oxalate excretion from before and after supplementation 7 days
Enrollment 45
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Aloe vera with cactus

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.

Arm group label: Aloe vera with cactus

Other name: Walgreens

Intervention type: Dietary Supplement

Intervention name: Cranberry

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.

Arm group label: Cranberry

Other name: Puritan's Pride

Intervention type: Dietary Supplement

Intervention name: Green tea extract

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.

Arm group label: Green tea extract

Other name: Puritan's Pride

Intervention type: Dietary Supplement

Intervention name: Bilberry

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.

Arm group label: Bilberry

Other name: Puritan's Pride

Intervention type: Dietary Supplement

Intervention name: Cinnamon

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.

Arm group label: Cinnamon

Other name: Puritan's Pride

Intervention type: Dietary Supplement

Intervention name: Milk thistle

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.

Arm group label: Milk thistle

Other name: Puritan's Pride

Intervention type: Dietary Supplement

Intervention name: Turmeric

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.

Arm group label: Turmeric

Other name: Puritan's Pride

Intervention type: Dietary Supplement

Intervention name: Aloe vera

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.

Arm group label: Aloe vera

Other name: Puritan's Pride

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kristina L Penniston, PhD, RD Principal Investigator Department of Urology, University of Wisconsin School of Medicine and Public Health
Location
facility Department of Urology, School of Medicine & Public Health, University of Wisconsin
Location Countries

United States

Verification Date

October 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 8
Arm Group

Arm group label: Aloe vera with cactus

Arm group type: Experimental

Description: 1 capsule (500 mg), 2 times/day

Arm group label: Cranberry

Arm group type: Experimental

Description: 3 capsules (810 mg), 2 times/day

Arm group label: Green tea extract

Arm group type: Experimental

Description: 2 capsules (630 mg), 2 times/day

Arm group label: Bilberry

Arm group type: Experimental

Description: 1 softgel (1000 mg), 2 times/day

Arm group label: Cinnamon

Arm group type: Experimental

Description: 1 capsule (500 mg), 2 times/day

Arm group label: Milk thistle

Arm group type: Experimental

Description: 1 capsule (250 mg), 3 times/day

Arm group label: Turmeric

Arm group type: Experimental

Description: 1 capsule (450 mg turmeric + 50 mg turmeric extract), 1 time/day

Arm group label: Aloe vera

Arm group type: Experimental

Description: 1 capsule (470 mg), 2 times/day

Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov