Evaluation of Multiple Alkalinizing Agents on Urinary Stone Risk Parameters in Stone and Non-stone Formers on a Metabolically Controlled Diet
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- 24 hour urine calcium
研究概览
简要总结
The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.
详细描述
Kidney stones are a common medical problem, occurring in almost 10% of people in the United States1. Furthermore, 50% of patients will recur within 10 years2. Metabolic testing is advised in recurrent stone formers, as well as those considered high risk, to assess for a specific abnormality which may prompt intervention to prevent future stone formation. Non-surgical interventions include both dietary counselling, as well as pharmacotherapy.
One of the most commonly prescribed class of pharmacotherapies is alkali therapy which can be used to both increase the urinary pH and raise the urine citrate levels. This is particularly useful as correction of very acidic urinary pH (<5.5) can counteract uric acid crystallization thereby preventing or even dissolving uric acid stones3. Further, citrate has been shown to be a potent inhibitor of calcium stones by binding to the calcium directly4 and inhibiting crystal nucleation, thereby reducing calcium stone formation5,6.
The most commonly utilized preparation of alkali therapy is potassium citrate which has been shown to prevent stone formation better than sodium citrate7. Unfortunately, some forms of potassium citrate (crystal packets) have become unavailable, and the slow release form of potassium citrate (UroCit-K) now exceeds $15/day in cost8. There have been multiple alternative alkali therapies that have been used in place of potassium citrate, including both medical foods and prescription medications, but with little evidence to support their use. A pilot study in order to quantify the metabolic effects of these agents and compare them to potassium citrate will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 and older.
- •with or without a history of stone disease.
排除标准
- •They are unable to take any of the medications due to health reasons.
- •Participants are pregnant or nursing.
- •Participants are unable to adhere to the metabolic diet.
- •Participants had a prior adverse event from one or more of the medications.
研究组 & 干预措施
Potassium citrate
干预措施: Potassium Bicarbonate (Drug)
Litholyte arm
干预措施: Potassium Bicarbonate (Drug)
Metabolic diet
Controlled metabolic diet arm.
干预措施: Potassium citrate (Drug)
Metabolic diet
Controlled metabolic diet arm.
干预措施: Sodium bicarbonate (Drug)
Metabolic diet
Controlled metabolic diet arm.
干预措施: Litholyte (Dietary Supplement)
Metabolic diet
Controlled metabolic diet arm.
干预措施: Crystal Lite (Dietary Supplement)
Metabolic diet
Controlled metabolic diet arm.
干预措施: Potassium Bicarbonate (Drug)
Potassium citrate
干预措施: Potassium citrate (Drug)
Potassium citrate
干预措施: Sodium bicarbonate (Drug)
Potassium citrate
干预措施: Litholyte (Dietary Supplement)
Potassium citrate
干预措施: Crystal Lite (Dietary Supplement)
Sodium Bicarbonate
干预措施: Potassium citrate (Drug)
Sodium Bicarbonate
干预措施: Sodium bicarbonate (Drug)
Sodium Bicarbonate
干预措施: Litholyte (Dietary Supplement)
Sodium Bicarbonate
干预措施: Crystal Lite (Dietary Supplement)
Sodium Bicarbonate
干预措施: Potassium Bicarbonate (Drug)
Litholyte arm
干预措施: Potassium citrate (Drug)
Litholyte arm
干预措施: Sodium bicarbonate (Drug)
Litholyte arm
干预措施: Litholyte (Dietary Supplement)
Litholyte arm
干预措施: Crystal Lite (Dietary Supplement)
Crystal Lite
干预措施: Potassium citrate (Drug)
Crystal Lite
干预措施: Sodium bicarbonate (Drug)
Crystal Lite
干预措施: Litholyte (Dietary Supplement)
Crystal Lite
干预措施: Crystal Lite (Dietary Supplement)
Crystal Lite
干预措施: Potassium Bicarbonate (Drug)
Potassium Bicarbonate
干预措施: Potassium citrate (Drug)
Potassium Bicarbonate
干预措施: Sodium bicarbonate (Drug)
Potassium Bicarbonate
干预措施: Litholyte (Dietary Supplement)
Potassium Bicarbonate
干预措施: Crystal Lite (Dietary Supplement)
Potassium Bicarbonate
干预措施: Potassium Bicarbonate (Drug)
结局指标
主要结局
24 hour urine calcium
时间窗: Change from baseline (Day 4) to end of study (day 12)
urine calcium
24 hours urine uric acid
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine Uric Acid
24 hours urine oxalate
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine oxalate
24 hours urine magnesium
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine magnesium
24 hours urine ammonia
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine ammonia
24 hour urine phosphorus
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine phosphorus
24 hour urine creatinine
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine creatinine
24 hour urine sulfate
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine sulfate
24 hour urine volume
时间窗: Change from baseline (Day 4) to end of study (day 12)
Total urine volume
24 hour urine potassium
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine potassium
24 hours urine sodium
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine sodium
24 hour urine sodium
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine sodium
24 hours urine citrate
时间窗: Change from baseline (Day 4) to end of study (day 12)
Urine citrate
24 Hour Urine pH
时间窗: Change from baseline (Day 4) to end of study (day 12)
Overal Urine pH from 24h urine sample.
24 hour urine volume
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Total urine volume
24 hour urine creatinine
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine creatinine
24 hour urine calcium
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
urine calcium
24 hour urine potassium
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine potassium
24 hours urine citrate
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine citrate
24 hours urine uric acid
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine uric acid
24 hours urine oxalate
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine oxalate
24 hours urine magnesium
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine magnesium
24 hours urine ammonia
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine ammonia
24 Hour Urine pH
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Overal Urine pH from 24h urine sample.
24 hour urine phosphorus
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine phosphorus
24 hour urine sulfate
时间窗: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine sulfate
次要结局
- Total out of pocket cost(At the end of study approximately 10 weeks after start of study.)
- Patient's GI Distress(At the end of study approximately 10 weeks after start of study.)
- # of patient who adherence to 100% Medication(At the end of study approximately 10 weeks after start of study.)
- Patient's Satisfaction Survey(At the end of study approximately 10 weeks after start of study.)
研究者
Brett Johnson
Associate Professor of Urology
University of Texas Southwestern Medical Center