Reduced Phosphate Intake in "Normo-Phosphatemic" Chronic Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Fibroblast Growth Factor 23 (FGF-23)
研究概览
简要总结
The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.
详细描述
Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients with chronic kidney disease, the kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can accumulate in the walls of blood vessels leading to heart disease, their leading cause of death. A recently discovered hormone called FGF-23 helps control the blood levels of phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of this study is to learn more about how FGF-23 helps the kidneys control the blood levels of phosphorus. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with stage 3a, 3b and 4 CKD
- •subjects have to be aged 18 years or older
- •subjects have to have normal serum phosphate levels (< 4.6 mg/dl)
- •subjects have to have sufficient 25-OH Vit0amin D levels (≥ 20 ng/ml)
排除标准
- •subjects with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
- •subjects expected to require dialysis initiation within the follow up period
- •subjects with hyperphosphatemia > 4.6 mg/dL
- •subjects with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
- •subjects with malnutrition, defined as a serum albumin < 3.0 mg/dl, in order to avoid worsening protein-malnutrition status during the restricted study period since phosphate restricted diets are also low in protein
- •subjects with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue
- •subjects with liver disease (ALT or AST > 100 U/L) or cholestasis (direct bilirubin > 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D
- •subjects with anemia, defined as a hematocrit <27% at the screening visit
- •subjects wht have been hospitalization within the previous 4 weeks
- •subjects who are pregnant
- •subjects who are breastfeeding mothers
- •subjects with primary hypoparathyroidism
- •subjects with primary hyperparathyroidism
- •subjects with previous subtotal parathyroidectomy
- •subjects with previous outpatient counseling by a renal nutritionist
- •subjects who are unable to independently provide written informed consent - prisoners, mentally incompetent, minors
研究组 & 干预措施
Lanthanum Carbonate and Low Phosphorus Diet
25% of subjects will receive binders plus a phosphate restricted diet.
干预措施: Lanthanum Carbonate (Drug)
Lanthanum Carbonate and Low Phosphorus Diet
25% of subjects will receive binders plus a phosphate restricted diet.
干预措施: Low Phosphorus Diet (Dietary Supplement)
Lanthanum Carbonate and Unrestricted Phosphorus Diet
25% binders + unrestricted phosphate diet.
干预措施: Lanthanum Carbonate (Drug)
Lanthanum Carbonate and Unrestricted Phosphorus Diet
25% binders + unrestricted phosphate diet.
干预措施: Unrestricted Phosphorus Diet (Dietary Supplement)
Placebo and Low Phosphorus Diet
25% placebo + phosphate restricted diet.
干预措施: Low Phosphorus Diet (Dietary Supplement)
Placebo and Low Phosphorus Diet
25% placebo + phosphate restricted diet.
干预措施: Placebo (Drug)
Placebo and Unrestricted Phosphorus Diet
25% placebo + unrestricted phosphate diet.
干预措施: Unrestricted Phosphorus Diet (Dietary Supplement)
Placebo and Unrestricted Phosphorus Diet
25% placebo + unrestricted phosphate diet.
干预措施: Placebo (Drug)
结局指标
主要结局
Fibroblast Growth Factor 23 (FGF-23)
时间窗: 2 weeks
Plasma FGF-23 was measured using c-terminal FGF23 assay.
次要结局
- 24-hour Urinary Phosphate(2 weeks)
研究者
Myles S. Wolf
Associate Professor
Massachusetts General Hospital