Status:
COMPLETED
The Effect of Cholecalciferol in Pre-frail Elderly
Lead Sponsor:
Indonesia University
Conditions:
Pre-frail Elderly
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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. T...
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, l...
Eligibility Criteria
Inclusion
- Pre-frail elderly
- Capable to understand and carry-out the instruction
Exclusion
- 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
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04847947
Start Date
April 19 2021
End Date
December 31 2021
Last Update
January 26 2023
Active Locations (1)
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1
Cipto Mangunkusumo General Hospital
Jakarta, DKI Jakarta, Indonesia, 10430