Phase 3 Study of Vitamin D Analog (Alfacalcidol) on Muscle Strength in Elderly Indonesian Women Who Have Low Handgrip Strength
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Improvement of muscle strength in the group that received alfacalcidol compared to placebo
研究概览
简要总结
The age-related increase in falls is strongly associated with a decline in muscle strength by the mechanism of sarcopenia. There has been great interest in developing approaches to counteract the effects of sarcopenia, and thereby reduce the age-related decline in muscle mass with vitamin D that have muscular effect. However, a limited number of studies demonstrate a vitamin D analog (alfacalcidol) increase in lower body muscle strength in adults with vitamin D deficiency. A double-blinded randomized controlled trial was conducted in order to determine the effect of alfacalcidol on the upper-body muscle strength in Indonesian elderly women in age group of 60 or more who had low handgrip strength.
详细描述
A total 122 elderly women were enrolled to this study. It was determined subjects with handgrip strength less than 22 kg and measured using handheld dynamometer. There were 95 subjects fulfilled the eligible criteria. These subjects were randomized into two groups, one group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo. Each subject was given calcium 500 mg/day. After 12 weeks of intervention, 88 subjects had the second muscle strength measurement (7 dropped out).
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elderly women in age group of 60 or more
- •Subjects with handgrip strength less than or equal to 22 kg
排除标准
- •Hypercalcemia (serum calcium > 10.5 mg / dL)
- •Can not understand instructions well (MMSE scale < 16)
- •Depression (Geriatric Depression Scale> 10)
- •Fracture, deformity, and pain with a visual analog scale (VAS) ≥ 4 on fingers and joints of the upper limb when the examination will be conducted
- •Heart failure fc. III-IV or uncontrolled according to the New York Heart Association (NYHA)
- •Neurological conditions (epilepsy, acute stroke, Parkinson's)
- •Malignant hypertension (systolic blood pressure ≥ 200 mmHg and or diastolic blood pressure ≥ 120 mmHg)
- •Blood malignancies and solid tumors
- •Decreased function of the liver (cirrhosis, ALT increase above 2 times the upper normal limit )
- •Refusing to follow the research / not willing controls
研究组 & 干预措施
alfacalcidol
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo
干预措施: alfacalcidol (Drug)
结局指标
主要结局
Improvement of muscle strength in the group that received alfacalcidol compared to placebo
时间窗: 12 weeks
After 12 weeks of intervention, 88 subjects had the second muscle strength measurement
次要结局
未报告次要终点