Overview

The Effect of Cholecalciferol in Pre-frail Elderly

Status:
Recruiting

Trial end date:
2021-12-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Indonesia University

Treatments:

Cholecalciferol
Vitamin D

Criteria

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