Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk
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
1 capsule (500 mg), 2 times/day
干预措施: Aloe vera with cactus (Dietary Supplement)
Aloe vera
1 capsule (470 mg), 2 times/day
干预措施: Aloe vera (Dietary Supplement)
Turmeric
1 capsule (450 mg turmeric + 50 mg turmeric extract), 1 time/day
干预措施: Turmeric (Dietary Supplement)
Milk thistle
1 capsule (250 mg), 3 times/day
干预措施: Milk thistle (Dietary Supplement)
Cinnamon
1 capsule (500 mg), 2 times/day
干预措施: Cinnamon (Dietary Supplement)
Bilberry
1 softgel (1000 mg), 2 times/day
干预措施: Bilberry (Dietary Supplement)
Green tea extract
2 capsules (630 mg), 2 times/day
干预措施: Green tea extract (Dietary Supplement)
Cranberry
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
