The Effect of Cholecalciferol on Frailty Syndrome in Pre-frail Elderly Receiving Calcium Supplementation : A Study on Handgrip Strength, Gait Speed, Vitamin D Receptor, Insulin Growth Factor-1 and Interleukin-6
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Handgrip strength
研究概览
简要总结
Vitamin D plays important role in musculoskeletal health and has been known to influence immune system. Inflammaging is one of risk factors that may contribute to development of frailty in elderly.
The purpose of this study is to determine the effects of cholecalciferol in pre-frail elderly receiving calcium supplementation on handgrip strength, gait speed, vitamin D receptor, IGF-1 and IL-6. Fall incidence and improvement of frailty status will also be assessed.
详细描述
This is a randomized double-blind placebo-controlled study in pre-frail elderly. Measurement of frailty status based on Fried frailty phenotype criteria (weight loss, weakness, exhaustion, slowness, low physical activity level) .
Subjects who fulfill eligibility criteria will be randomized into 2 groups, one group will received cholecalciferol 4000 IU once daily and the other group will received placebo once daily. Each subjects in both groups will received calcium lactate 500 mg once daily. Intervention will be held for 12 weeks.
Handgrip strength and gait speed will be assessed at baseline, every 4 weeks, and at week 12. Other outcome measures will be assessed at baseline and at week 12.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-frail elderly
- •Capable to understand and carry-out the instruction
排除标准
- •Allergic to cholecalciferol, calcium, or its components
- •Hypercalcemia (total serum calcium > 10,5 mg/dL)
- •Unwilling to stop using drug contain vitamin D or vitamin D analog or calcium
- •Using steroid or NSAID routinely
- •Acute illness during inclusion period, eg. pneumonia, stroke attack, acute exacerbation of chronic obstructive pulmonary disease, asthma attack, hypertensive urgency/emergency, acute decompensated heart failure
- •Having condition that can affect measurement of handgrip strength and gait speed, eg. hemiparesis, severe pain in extremities
- •Hepatic cirrhosis, malignancy, autoimmune disease, nephrolithiasis, malabsorption syndrome (eg. chronic diarrhea) , diabetes mellitus with HbA1c > = 8% in the last 3 months, diabetes mellitus with obvious sign and symptoms of catabolic decompensation (polyphagia, polydipsia, polyuria), chronic kidney disease stage IV-V or decreased renal function with estimated glomerular filtration rate < 30 ml/minute/1,73 m2
- •Using drug that can affect vitamin D absorption, eg. bile acid sequestrants
- •Cognitive impairment (Abbreviated Mental Test score < 8)
- •Depression (Geriatric Depression Scale score > = 10)
- •Unwilling to join the study
研究组 & 干预措施
Interventional group
Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks.
干预措施: Cholecalciferol (Drug)
Control Group
Oral capsule Placebo once daily and Calcium Lactate 500 mg once daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Handgrip strength
时间窗: 12 weeks (evaluation every 4 weeks)
Change from baseline in handgrip strength. Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer )
Gait speed
时间窗: 12 weeks (evaluation every 4 weeks)
Change from baseline in gait speed. Measurement: 15-feet walking test
次要结局
- Vitamin D receptor (VDR) monocyte level(12 weeks)
- Interleukine 6 (IL-6) monocyte level(12 weeks)
- Insulin Growth Factor-1 (IGF-1) monocyte level(12 weeks)
- serum VDR level(12 weeks)
- Serum IGF-1 level(12 weeks)
- serum IL-6 level(12 weeks)
- Fall incidence(12 weeks)
- Frailty status(12 weeks)
研究者
dr. Noto Dwimartutie
, SpPD-KGer
Indonesia University