Analysis of Calcium Balance in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Calcium balance
研究概览
简要总结
Subjects with normal kidney function are able to excrete in their urine the calcium and phosphorus absorbed via the gastrointestinal tract and are thereby are able to maintain calcium and phosphorus balance. Patients with chronic kidney disease often have normal blood levels of calcium and phosphorus but no research has been conducted to determine if they are able to excrete their daily intake of these minerals. If they are not able to excrete their daily intake, these minerals could be deposited in soft tissue and blood vessels and contribute to the increased risk of cardiovascular disease seen in patients with chronic kidney disease. This study will determine if subjects with chronic kidney disease are in balance primarily with regard to calcium and at what level of kidney function they are no longer able to maintain balance. Understanding whether patients with chronic kidney disease are in balance will help direct future therapeutic interventions.
详细描述
We hypothesize that by Chronic Kidney Disease (CKD) late Stage 3 and Stage 4 patients are no longer able to maintain calcium balance by excreting their daily intake of calcium. We also hypothesize that the retention of calcium is not reflected in the serum concentration, as the body attempts to maintain the serum calcium concentration within narrow limits.
We will evaluate balance at two different levels of calcium intake. The two different levels were chosen to be at the extremes of normal calcium intake to provide insight into balance at low normal and high normal loads.
Specific expected experimental finding:
Directional Hypotheses:
Primary Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Men and women 18 years of age or greater and able to comply with the study protocol.
- •eGFR within appropriate target ranges (15-40 ml/min/m² for late stage CKD stage 3 stage 4, and eGFR > 60 ml/min/m² for normal subjects)
- •Stable kidney function defined as an eGFR which remains within a 10ml/min range over a 3 to 6 month period prior to study enrollment. This will be determined from historical laboratory data.
- •Willing to follow study protocol
- •Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
- •Overall stable medical condition, defined as no malignancy, metabolic condition or gastrointestinal condition that would make it difficult to comply with the study protocol and complete both dietary study periods
- •Able to read the consent form and provide informed consent.
- •Serum calcium and phosphorus within the normal range off of vitamin D analogues, calcium supplements, and phosphate binders for 1 month.
排除标准
- •Age less than 18 years
- •Are pregnant, plan on becoming pregnant during the study period, or breast-feeding, if female.
- •Patient declines participation.
- •GI malabsorption, short bowel syndrome, frequent vomiting, or gastroparesis.
- •Subject receiving synthetic parathyroid hormone, glucocorticoids, calcitonin or bisphosphonates.
结局指标
主要结局
Calcium balance
时间窗: 48 hour
次要结局
- Phosphorus balance(48 hours)
- PTH(2 WEEKS)
- FGF-23(2 WEEKS)