Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease: A Randomized Controlled Trial (CARDIA Ancillary Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Difference between the two arms in supersaturation of calcium oxalate
研究概览
简要总结
The true capacity for a healthy diet to improve urinary stone risk factors is not well-defined. The objective of this study is to measure the effect of adopting a healthy dietary pattern on kidney stone disease (KSD) risk. The working hypothesis is that a Dietary Approaches to Stop Hypertension (DASH)-style diet will improve 24-hour urine stone risk parameters. The approach to testing this hypothesis will be to randomize participants with KSD to a standardized DASH-style vs. Western-style diet for one week. The Bionutrition Unit of the Center for Clinical and Translational Science will provide all meals to participants. The rationale for this study is that by measuring the effect of a DASH-style diet on urinary stone risk parameters, a benchmark for future real-world, implementation studies will be established. Based on available evidence, this will be the first controlled diet study to assess the DASH dietary pattern for improving urinary stone risk parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birmingham, AL area participants of the Coronary Artery Risk Development in Young Adults (CARDIA) study OR patients of the University of Alabama at Birmingham/Kirklin Clinic
- •Self-reported, documented, and/or prior imaging-based diagnosis of kidney stone disease
- •Age 19-89
- •Able to provide informed consent
- •Willing to perform 24-hour urine collections
- •Willing to consume meals prepared by Bionutrition Unit
- •No food allergies/intolerance to any of the foods in the study menus
- •Willing to stop for 7 days before and during study: Multivitamins and/or Dietary supplements (including calcium and vitamin C)
排除标准
- •Kidney transplant recipient
- •Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 based on historical laboratory measurements
- •Renal tubular acidosis
- •Current use of acetazolamide, topiramate, or zonisamide
- •Primary hyperparathyroidism or history of parathyroidectomy
- •Hyperthyroidism
- •Sarcoidosis
- •Primary hyperoxaluria
- •Cystinuria
- •Nephrotic syndrome
- •Malabsorptive conditions including inflammatory bowel disease or history of malabsorptive surgery (e.g., Roux-en-Y gastric bypass, small bowel resection)
- •Urinary retention requiring catheterization
- •Urinary diversion
- •Pregnancy
- •Breastfeeding
- •Malignancy treated in the past 12 months other than non-melanoma skin cancer
结局指标
主要结局
Difference between the two arms in supersaturation of calcium oxalate
时间窗: Days 6-7 of the assigned intervention
Supersaturation of calcium oxalate is an index reflecting the propensity for the formation and growth of the most common stone type (calcium oxalate), which is calculated using excretion rates including urinary volume, calcium, citrate, and oxalate.
次要结局
- Difference between the two arms in supersaturation of uric acid(Days 6-7 of the assigned intervention)
- Difference between the two arms in urine uric acid(Days 6-7 of the assigned intervention)
- Difference between the two arms in supersaturation of calcium phosphate(Days 6-7 of the assigned intervention)
- Difference between the two arms in urine volume(Days 6-7 of the assigned intervention)
- Difference between the two arms in urine oxalate(Days 6-7 of the assigned intervention)
- Difference between the two arms in urine citrate(Days 6-7 of the assigned intervention)
- Difference between the two arms in urine calcium(Days 6-7 of the assigned intervention)
- Difference between the two arms in urine pH(Days 6-7 of the assigned intervention)
- Difference between the two arms in supersaturation of calcium oxalate between the baseline and intervention periods(Days 6-7 of the assigned intervention)
研究者
Joseph Crivelli
Assistant Professor of Urology
University of Alabama at Birmingham