The Effect of Cholecalciferol in Pre-frail Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pre-frail Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Interventional group

Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks.

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks

Control Group

Oral capsule Placebo once daily and Calcium Lactate 500 mg once daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Cholecalciferol

Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Vitamin D3 Prove D3

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No