Dose Finding Study in Physically Frail Elderly to Measure 25(OH) Vitamin D Levels After Supplementation With Hy.D Calcifediol 25 SD/S and Vitamin D3
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baseline
研究概览
简要总结
The purpose of this study is to assess the dose of Hy.D Calcifediol 25 SD/S (a metabolite of vitamin D3) which will achieve the range of mean serum 25(OH)D between 75-100nmol/L in physically frail elderly people after 24 weeks of daily supplementation with different doses of Hy.D Calcifediol 25 SD/S compared to vitamin D3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •25(OH)D levels between 25 - 50 nmol/L;
- •Age 65 and older;
- •Physically frail, based on the criteria designed by Fried et al. [1]. Frailty will be defined as a clinical syndrome in which one or more of the following criteria are present: unintentional weight loss (4.5 kg in past year), selfreported exhaustion (CES-D questionnaire), weakness (grip strength), slow walking speed and low physical activity (Minnesota questionnaire). These criteria are easily assessable and have been commonly used to determine frailty;
- •Men and women;
- •Body mass index between 20 and 35 kg/m2 (used for stratification);
- •Willingness and ability to comply with the protocol.
排除标准
- •Medical Illness: malabsorption syndrome: known intestinal malabsorption, celiac diseases, inflammatory bowel disease; diseases that may enhance serum calcium concentration: sarcoidosis, lymphoma, kidney stone in the last 10 years, primary hyperparathyroidism; abnormal indices of calcium metabolism, uncontrolled hypocalcaemia; diagnosed renal insufficiency, diagnosed cancer, diagnosed liver failure.
- •Hypercalcemia : serum calcium adjusted for albumin of > 2.6 nmol/L.
- •Medication: bisphosphonate or Parathyroid hormone (PTH) treatment, tuberculostatics, epilepsy medication, interfering with vitamin D metabolism and vitamin D supplementation.
- •Use of vitamin D supplementation in the last three months (excluding multivitamin supplementation).
- •Not willing to stop the use of multivitamin supplementation during the study.
- •(Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort).
- •Patient heavily consumes alcohol containing products defined as greater than (>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
- •Donating blood in the period of 2 months before, until 1 month after the end of the study.
- •Planned surgery.
- •Participation in another clinical trial.
结局指标
主要结局
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baseline
时间窗: Baseline (day 0)
Outcome measurement: Mean serum 25(OH)D levels at baseline before supplementation of three doses of Hy.D and 1 dose of vitamin D3.
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 4 weeks
时间窗: 4 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 4 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 8 weeks
时间窗: 8 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 8 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 12 weeks
时间窗: 12 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 12 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 16 weeks
时间窗: 16 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 16 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 20 weeks
时间窗: 20 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 20 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks
时间窗: 24 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 24 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
次要结局
- Descriptive: 25(OH)D3 serum steady state reached?(0, 4, 8, 12, 16, 20, 24 weeks after study start)