Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04847947
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2021-04-13
Brief Title:
The Effect of Cholecalciferol in Pre-frail Elderly
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Effect of Cholecalciferol on Frailty Syndrome in Pre-frail Elderly Receiving Calcium Supplementation A Study on Handgrip Strength Gait Speed Vitamin D Receptor Insulin Growth Factor-1 and Interleukin-6
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None