NCT00692120已完成不适用
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.
研究概览
简要总结
Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D. Additionally, it will evaluate whether once per month vitamin D dosing is as effective in maintaining blood vitamin D levels as daily dosing.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community dwelling men and women age ≥ 65 years.
- •Able and willing to sign informed consent.
- •Serum 25OHD concentration ≥ 10 and less than 60 ng/ml by HPLC.
- •Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed
排除标准
- •Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
- •History of nephrolithiasis.
- •Screening 25OHD concentration ≥ 60 ng/ml.
- •Baseline 24-hour urine calcium > 250 mg if female, > 300 mg if male.
- •Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease
- •History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin cancer.
- •Renal failure defined as a calculated creatinine clearance (Cockroft-Gault method) ≤ 25 ml/minute
- •Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which may limit ability to complete the study
- •Known malabsorption syndromes, e.g., celiac disease, radiation enteritis, active inflammatory bowel disease, etc.
- •Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, PTH, testosterone or calcitonin
- •Vitamin D intake greater than 5,000 IU daily
- •Treatment with any active metabolites of vitamin D within six months of screening
- •Treatment with any drug which may interfere with vitamin D metabolism, e.g., phenobarbital, phenytoin.
结局指标
主要结局
The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.
时间窗: 12 months
次要结局
- Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status(12 months)
- Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance(12 months)
研究者
研究点 (2)
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