Randomized Cross-over Study Examining the Effects of Phosphorus Additives on Urinary Albumin Excretion and Fibroblast Growth Factor-23
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- 24-hour Urine Albumin Excretion
研究概览
简要总结
Phosphorus-based food additives are commonly used by food manufacturers for many applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these additives can significantly increase an individual's daily phosphorus intake, little is known about the effect of dietary phosphorus on kidney health. In this study, the investigators will first lower baseline phosphorus intake to about 1000mg/d by educating participants to avoid foods with phosphorus additives. Then, participants will be randomized to a higher phosphorus period (~2gm/d) and a lower phosphorus period (~1gm/d) by providing unaltered, commercially-available food/beverage products with and without phosphorus additives.
The investigators hypothesize that participants will have higher urine albumin excretion and fibroblast growth factor-23 (FGF-23) during the higher phosphorus period compared to the lower phosphorus period.
详细描述
The Study of Dietary Additive Phosphorus on Proteinuria and FGF-23 (SODA-POP) was a single-center, randomized, double-blind, two-period cross-over study that examined the effect of higher vs. lower phosphorus intake for 3 week periods, achieved by addition of commercially available diet beverages and breakfast bars to diet on albuminuria and fibroblast growth factor 23, in adults with presumed early chronic kidney disease (estimated glomerular filtration rate >= 45 ml/min/1.73m2; and urine albumin/creatinine ratio >=17 mg/g for men or >=25 mg/g for women).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults at least 21 years of age with at least microalbuminuria
排除标准
- •Estimated glomerular filtration rate <45ml/min/1.73m2, poorly controlled diabetes or hypertension, nephrotic syndrome, hyperparathyroidism, Paget's Disease, multiple myeloma, uncontrolled thyroid disease, chronic antacid use, use of phosphorus binders, phosphorus supplements, or high-dose vitamin D, inability to complete feeding study, investigator discretion
结局指标
主要结局
24-hour Urine Albumin Excretion
时间窗: 3 weeks
Two 24-hour urine collections will be collected during the 3rd week of each period
Fibroblast Growth Factor-23 (FGF-23)
时间窗: 3 weeks
Plasma FGF-23 will be measured at the end of each 3 week period in the morning after an overnight fast. As this is a small pilot study, we will not adjust for multiple comparisons. A p value\<0.05 will be considered statistically significant for both outcomes
次要结局
- Systolic Blood Pressure(2-3 weeks)
- Diastolic Blood Pressure(2-3 weeks)
研究者
Alexander Chang
Clinical Investigator
Geisinger Clinic