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临床试验/NCT02404701
NCT02404701已完成不适用

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

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Within-subject change in 24-hour urinary oxalate excretion from before and after supplementation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •At least 18 years of age, no prior personal history of kidney stones

排除标准

  • •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.

研究组 & 干预措施

Aloe vera with cactus

Experimental

1 capsule (500 mg), 2 times/day

干预措施: Aloe vera with cactus (Dietary Supplement)

Aloe vera

Experimental

1 capsule (470 mg), 2 times/day

干预措施: Aloe vera (Dietary Supplement)

Turmeric

Experimental

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

干预措施: Turmeric (Dietary Supplement)

Milk thistle

Experimental

1 capsule (250 mg), 3 times/day

干预措施: Milk thistle (Dietary Supplement)

Cinnamon

Experimental

1 capsule (500 mg), 2 times/day

干预措施: Cinnamon (Dietary Supplement)

Bilberry

Experimental

1 softgel (1000 mg), 2 times/day

干预措施: Bilberry (Dietary Supplement)

Green tea extract

Experimental

2 capsules (630 mg), 2 times/day

干预措施: Green tea extract (Dietary Supplement)

Cranberry

Experimental

3 capsules (810 mg), 2 times/day

干预措施: Cranberry (Dietary Supplement)

结局指标

主要结局

Within-subject change in 24-hour urinary oxalate excretion from before and after supplementation

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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