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

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ClinicalTrials.gov Identifier: NCT02404701
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperoxaluria Dietary Supplement: Aloe vera with cactus Dietary Supplement: Cranberry Dietary Supplement: Green tea extract Dietary Supplement: Bilberry Dietary Supplement: Cinnamon Dietary Supplement: Milk thistle Dietary Supplement: Turmeric Dietary Supplement: Aloe vera Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk
Study Start Date : February 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aloe vera with cactus
1 capsule (500 mg), 2 times/day
Dietary Supplement: Aloe vera with cactus
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.
Other Name: Walgreens

Experimental: Cranberry
3 capsules (810 mg), 2 times/day
Dietary Supplement: Cranberry
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.
Other Name: Puritan's Pride

Experimental: Green tea extract
2 capsules (630 mg), 2 times/day
Dietary Supplement: Green tea extract
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.
Other Name: Puritan's Pride

Experimental: Bilberry
1 softgel (1000 mg), 2 times/day
Dietary Supplement: Bilberry
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.
Other Name: Puritan's Pride

Experimental: Cinnamon
1 capsule (500 mg), 2 times/day
Dietary Supplement: Cinnamon
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.
Other Name: Puritan's Pride

Experimental: Milk thistle
1 capsule (250 mg), 3 times/day
Dietary Supplement: Milk thistle
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.
Other Name: Puritan's Pride

Experimental: Turmeric
1 capsule (450 mg turmeric + 50 mg turmeric extract), 1 time/day
Dietary Supplement: Turmeric
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.
Other Name: Puritan's Pride

Experimental: Aloe vera
1 capsule (470 mg), 2 times/day
Dietary Supplement: Aloe vera
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.
Other Name: Puritan's Pride




Primary Outcome Measures :
  1. Within-subject change in 24-hour urinary oxalate excretion from before and after supplementation [ Time Frame: 7 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404701


Locations
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United States, Wisconsin
Department of Urology, School of Medicine & Public Health, University of Wisconsin
Madison, Wisconsin, United States, 53705-2281
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Kristina L Penniston, PhD, RD Department of Urology, University of Wisconsin School of Medicine and Public Health

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02404701     History of Changes
Other Study ID Numbers: 2015-0076
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Turmeric extract
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs