Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Serum Parathyroid Hormone (PTH) Level
研究概览
简要总结
This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.
详细描述
Primary hyperparathyroidism (PHPT) is a common disease in which the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. In primary hyperparathyroidism, high levels of PTH remove too much calcium from bones and deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by the excess calcium loss which weakens the structure of the bones.
Many patients with primary hyperparathyroidism also have low vitamin D (25OHD) levels which is thought to further impair bone health. Recent medical guidelines recommend treating patients with primary hyperparathyroidism who have low vitamin D levels with oral vitamin D but the optimal vitamin D dose and rate of repletion is unclear. It is, therefore, important to determine if replenishing Vitamin D will improve bone health in primary hyperparathyroidism, and if so, to assess the impact of the rate of vitamin D repletion.
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, Investigator, Outcomes Assessor)
盲法说明
Patient, investigator and study team will be blinded to study arm ramdomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed PHPT, defined by an elevated serum calcium level (we will not study normocalcemic PHPT) with elevated or inappropriately normal PTH levels.
- •Vitamin D3 less than 30 ng/ml
排除标准
- •Patients with familial hyperparathyroid syndromes
- •Current or past use of the following medications: bisphosphonate within past 2 years, use of lithium or thiazide diuretics, current use of cinacalcet, use of aluminum containing medications, cimetidine, colestipol, or orlistat
- •Malignancy, except cured basal or squamous cell skin carcinoma or other cured cancers that are at least five years free from recurrence
- •History or current diagnosis of certain medical diseases (including sarcoidosis, active infectious granulomatous disease, HIV/AIDS, chronic kidney disease (serum creatinine > 1.5 mg/dL), liver disease; GI diseases known to affect calcium metabolism; secondary hyperparathyroidism);
- •We will also exclude patients with calcium above 11.5 mg/dL, urine calcium above 350 mg/day, and active nephrolithiasis because vitamin D repletion could potentially exacerbate hypercalcemia or hypercalciuria
- •Other exclusions include protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.
研究组 & 干预措施
Group 1
10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D
干预措施: 10,000 IU Vitamin D3 (Drug)
Group 1
10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D
干预措施: Vitamin D (Dietary Supplement)
Group 2
Placebo plus a multivitamin with 400 IU vitamin D
干预措施: Placebo (Other)
Group 2
Placebo plus a multivitamin with 400 IU vitamin D
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Serum Parathyroid Hormone (PTH) Level
时间窗: 6 months
This is designed to measure how many participants will achieve PTH \> 65 pg/mL.
次要结局
- Areal Bone Mineral Density of the Lumbar Spine(6 months)
- Trabecular Bone Density at the Forearm(6 months)
- Change in Urinary Calcium Level(1 month, 3 months, 6 months)
研究者
Shonni J. Silverberg
Professor of Medicine
Columbia University