Physiologic Interactions Between the Adrenal- and the Parathyroid Glands
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Aldosterone, before and after 12 weeks of daily cholecalciferol treatment
研究概览
简要总结
To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.
详细描述
In primary hyperparathyroidism, chronic-elevated PTH levels seem to stimulate the renin-angiotensin-aldosterone system (RAAS) which may explain the increased risk of cardiovascular disease. In addition to increased PTH levels, vitamin D has been shown to inhibit the RAAS. However, a possible physiologic interaction needs further investigation.
The purpose of the study is to investigate changes in the RAAS in otherwise healthy postmenopausal women with secondary hyperparathyroidism due to vitamin D deficiency when p-PTH is normalized.
Furthermore, we will evaluate whether an angiotensin 2 receptor blocker can lower PTH in patients with secondary hyperparathyroidism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Secondary hyperparathyroidism due to Vitamin D deficiency
排除标准
- •Cardiovascular disease
- •Renal failure
- •Liver failure
- •Treatment with antihypertensive medication or diuretics
- •Treatment with lithium, NSAID or glucocorticoids
- •Calcium supplement more than 500 mg per day or Vitamin D supplement more than 25 microgram per day
- •Medical treatment for osteoporosis
- •Systolic blood pressure below 120 mmHg
- •Hypercalcaemia (more than 1,33mmol/L)
- •Use of solarium or planned trip to countries, that might increase the endogenous vitamin D synthesis
- •Allergic reaction to ACEi or ARBs.
研究组 & 干预措施
Cholecalciferol
Cholecalciferol 70 mcg/day for 12 weeks Placebo Valsartan daily for 2 weeks
干预措施: Cholecalciferol (Dietary Supplement)
Valsartan
Placebo cholecalciferol/day for 12 weeks Valsartan 80 mg/day for 2 weeks
干预措施: Valsartan (Drug)
Placebo
Placebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks
干预措施: Placebo Valsartan (Drug)
Placebo
Placebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks
干预措施: Placebo cholecalciferol (Dietary Supplement)
Cholecalciferol and Valsartan
Cholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks
干预措施: Valsartan (Drug)
Cholecalciferol and Valsartan
Cholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks
干预措施: Cholecalciferol (Dietary Supplement)
结局指标
主要结局
Aldosterone, before and after 12 weeks of daily cholecalciferol treatment
时间窗: Change from baseline p-aldosterone at 12 weeks
次要结局
- Bone density and geometry as measured by QCT scans(Change from baseline at 12 weeks)
- Balance as measured by stadiometer (Meitur Ltd)(Change from postural balance at 12 weeks)
- Muscle strength as measured by isometric tests(Change from baseline isometric muscle strength at 12 weeks)
- Quality of Life, SF36(Change from baseline at 12 weeks)
- Quality of Life, WHO-5(Change from baseline at 12 weeks)
- Physical activity(Change from baseline at 12 weeks)
- 24 hours arterial stiffness as measured by tonometry(Change from baseline arterial stiffness PWV at 12 weeks)
- Parathyroid hormone, before and after, daily ARB administrations(Change from baseline p-PTH at 2 weeks)
- Arterial stiffness(Change from baseline arterial stiffness at 12 weeks)
- 24 hours blood pressure measured by tonometry(Change from baseline systolic pressure at 12 weeks)
- Bone density and geometry as measured by HRpQCT scans(Change from baseline at 12 weeks)
- Bone density by DXA(Change from baseline at 12 weeks)
- Electrocardiogram(Change from baseline at 2, 6 and 12 weeks)
- Hyperparathyroid symptoms(Change from baseline at 12 weeks)
- Biomarkers of calcium- and bone metabolism(Change from baseline at 2, 6 and 12 weeks)