Assessing Human Phosphate Tolerance and Its Dependency on Age and Sex
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Phosphate in plasma
研究概览
简要总结
Kidney function declines with age and this could affect phosphate balance after an acute phosphate load (increased phosphate intake). In daily life, we regularly experience acute phosphate loads through our diet.
The aim of this clinical study is to determine whether the body's response to increased phosphate intake changes with age and whether there are sex differences in this response.
详细描述
Forty subjects (males and females aged 18-25 or 63-70) will ingest an oral phosphate load, after which their body's response will be assessed by collecting blood and urine samples over a period of ten hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers 18-25 and 63-70 years old
- •18.5 ≥ BMI < 26 kg/m2
- •0.84 ≥ phosphate in plasma ≤ 1.45 mM
- •2.20 ≥ calcium in plasma ≤ 2.50 mM
- •15 ≥ PTH in plasma ≤ 65 pg/ml
- •eGFR ≥ 60 ml/min/1-73 m2
- •90 ≥ Systolic blood pressure ≤ 140 mmHg
- •60 ≥ Diastolic blood pressure ≤ 85 mmHg
- •No hematuria and no acute urinary tract infection
- •Ability and willingness to participate in the study
- •Voluntary signed inform consent
排除标准
- •Diabetes mellitus
- •Pregnancy
- •History of kidney stones
- •History of parathyroidectomy
- •History of anorexia nervosa
- •History of bulimia
- •History of solid organ transplantation.
- •Nephrolithiasis
- •Sarcoidosis
- •Chronic pancreatitis
- •Chronic diarrhea
- •Chronic liver disease
- •Complete distal renal acidosis (dRTA)
- •Cystinuria
- •Hypo- or hyperaldosteronism
- •Hyper- or hypotension
- •Hypernatremia
- •Gastrointestinal disorders
- •Known hypersensitivity reactions to azoic dyes, acetylsalicylic acid, as well as antirheumatic drugs and painkillers (prostaglandin synthesis inhibitors).
- •Intake of vitamin D and calcium supplements, phosphate, bisphosphonates, cinacalcet, denusomab, teriparatide, systemic glucocorticoids or mineralcorticoids, antiepileptics, carboanydrase inhibitors or diuretics
研究组 & 干预措施
Oral phosphate load
Participants will eat a standard phosphate dinner. The next morning, after consuming a standard phosphate breakfast, they will ingest a phosphate load (558 mg phosphorus) and provide blood and urine samples for nine hours.
干预措施: Oral phosphate load (Other)
结局指标
主要结局
Phosphate in plasma
时间窗: The primary outcome will be measured 5 hours after the first blood collection on the day of the study and 4 hours after ingesting the oral phosphate load.
Phosphate in plasma 4 hours after the oral phosphate load shows age differences
次要结局
未报告次要终点