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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks
Oral capsule Placebo containing white rice flour in the same identical looking with active drug once daily and Calcium Lactate 500 mg once daily for 12 weeks
Cipto Mangunkusumo General Hospital
Jakarta, DKI Jakarta, Indonesia
Handgrip strength
Change from baseline in handgrip strength. Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer )
Time frame: 12 weeks (evaluation every 4 weeks)
Gait speed
Change from baseline in gait speed. Measurement: 15-feet walking test
Time frame: 12 weeks (evaluation every 4 weeks)
Vitamin D receptor (VDR) monocyte level
Change from baseline in VDR monocyte level. Measurement : flowcytometry
Time frame: 12 weeks
Interleukine 6 (IL-6) monocyte level
Change from baseline in IL-6 monocyte level. Measurement : flowcytometry
Time frame: 12 weeks
Insulin Growth Factor-1 (IGF-1) monocyte level
Change from baseline in IGF-1 monocyte level. Measurement : flowcytometry
Time frame: 12 weeks
serum VDR level
change from baseline in serum VDR level. Measurement : ELISA
Time frame: 12 weeks
Serum IGF-1 level
change from baseline in serum IGF-1 level. Measurement : ELISA
Time frame: 12 weeks
serum IL-6 level
change from baseline in serum IL-6 level. Measurement : ELISA
Time frame: 12 weeks
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Fall incidence
number of fall
Time frame: 12 weeks
Frailty status
improvement in frailty status
Time frame: 12 weeks