Pre-frail Elderly
Conditions
Keywords
Frailty, Pre-frail, Elderly, Cholecalciferol, Handgrip strength, Gait speed, Vitamin D receptor, Insulin Growth Factor-1, Interleukin-6
Brief summary
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.
Detailed description
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.
Interventions
DRUGCholecalciferol
Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks
DRUGPlacebo
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
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pre-frail elderly 2. Capable to understand and carry-out the instruction
Exclusion criteria
1. Allergic to cholecalciferol, calcium, or its components 2. Hypercalcemia (total serum calcium \> 10,5 mg/dL) 3. Unwilling to stop using drug contain vitamin D or vitamin D analog or calcium 4. Using steroid or NSAID routinely 5. 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 6. Having condition that can affect measurement of handgrip strength and gait speed, eg. hemiparesis, severe pain in extremities 7. 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 8. Using drug that can affect vitamin D absorption, eg. bile acid sequestrants 9. Cognitive impairment (Abbreviated Mental Test score \< 8) 10. Depression (Geriatric Depression Scale score \> = 10) 11. Unwilling to join the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | 12 weeks (evaluation every 4 weeks) | Change from baseline in handgrip strength. Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer ) |
| Gait speed | 12 weeks (evaluation every 4 weeks) | Change from baseline in gait speed. Measurement: 15-feet walking test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukine 6 (IL-6) monocyte level | 12 weeks | Change from baseline in IL-6 monocyte level. Measurement : flowcytometry |
| Insulin Growth Factor-1 (IGF-1) monocyte level | 12 weeks | Change from baseline in IGF-1 monocyte level. Measurement : flowcytometry |
| serum VDR level | 12 weeks | change from baseline in serum VDR level. Measurement : ELISA |
| Frailty status | 12 weeks | improvement in frailty status |
| serum IL-6 level | 12 weeks | change from baseline in serum IL-6 level. Measurement : ELISA |
| Fall incidence | 12 weeks | number of fall |
| Serum IGF-1 level | 12 weeks | change from baseline in serum IGF-1 level. Measurement : ELISA |
| Vitamin D receptor (VDR) monocyte level | 12 weeks | Change from baseline in VDR monocyte level. Measurement : flowcytometry |
Countries
Indonesia
Outcome results
None listed