Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 704
- 试验地点
- 1
- 主要终点
- Incidence of spontaneous falls.
研究概览
简要总结
The first objective is to determine the efficacy of calcium and vitamin D supplementation at doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in non-institutionalized elderly people.
The second objective is to measure and compare treatment groups (calcium and vitamin D vs placebo) as regards muscle strength and musculoskeletal function, bone mineral density, calcidiol level and treatment safety.
详细描述
Background:
There are many studies that associate vitamin D serum levels in older persons with muscle strength, physical performance and risk of fractures and falls. However, current evidence is insufficient to make a general recommendation for administrating calcium and vitamin D to older persons. The objective of this study is to determine the effectiveness of calcium and vitamin D supplementation in improving musculoskeletal function and decreasing the number of falls in person aged over 65 years.
Design:
Phase III, randomized, double blind, placebo-controlled trial to evaluate the efficacy of already marketed drugs in a new indication. It will be performed at Primary Care doctor visits at several Healthcare Centers in different Spanish Health Areas. A total of 704 non-institutionalized subjects aged 65 years or older will be studied (sample size calculated for a statistical power of 80%, alpha error 0.05, annual incidence of falls 30% and expected reduction of 30% to 20% and expected loss to follow up of 20%). The test drug containing 800 IU of vitamin D and 1000 mg of calcium will be administered daily. The control group will receive a placebo. The subjects will be followed up over two years. The primary variable will be the incidence of spontaneous falls. The secondary variables will include: consequences of the falls (fractures, need for hospitalization), change in calcidiol plasma levels and other analytical determinations (transaminases, PTH, calcium/phosphorous, albumin, creatinine, etc.), change in bone mass by densitometry, change in muscle strength in the dominant hand and change in musculoskeletal strength, risk factors for falls, treatment compliance, adverse effects and socio-demographic data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Aged over 65 years with normal renal function
- •Normal transaminase levels
- •Normal calcium blood levels
- •Not homebound (not immobilized) nor in socio-healthcare institutions.
排除标准
- •Need for medical treatment with calcium or vitamin D
- •Hypersensitivity to or contraindication for calcium or vitamin D
- •Medical treatment that includes calcium or vitamin D
- •Physical disability that impedes their collaboration
- •Taking thiazide diuretics
- •Oral anticoagulants
- •Hormone replacement therapy
- •Digitalis drugs
- •Anticonvulsants or barbiturates
- •Having any of the following diseases:
- •Lithiasis
- •Renal impairment (serum creatinine >1.4 mg/dl)
- •Hypo or hyperthyroidism
- •Paget's disease
- •Chronic liver disease
- •Sarcoidosis
- •Impaired intestinal absorption or chronic alcoholism (>40 g/day).
研究组 & 干预措施
Calcium and vitamin D
The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.
干预措施: Vitamin D and calcium suplementation (Drug)
结局指标
主要结局
Incidence of spontaneous falls.
时间窗: 24 months.
The primary variable will be the incidence of spontaneous falls according to the FICSIT (Frailty and Injury: Cooperative Study of Intervention Techniques) definition: "Unintentionally coming to rest on the ground, floor, or other lower level. Coming to rest against furniture or a wall was not counted as a fall".
次要结局
- Change in muscle strength in the dominant hand.(24 months)
- Consequence of falls.(24 months.)
- Change in calcidiol [25(OH)D3] plasma levels(18 months.)
- Change in bone mass (bone density or mineral content).(24 months.)
- Changes in musculoskeletal function.(24 months)
- Serious adverse events or any other adverse event.(24 months.)