The Effect of Cholecalciferol in Pre-frail Elderly

Phase 3

Completed

• Conditions: Pre-frail Elderly
• Interventions: Drug: Placebo; Drug: Cholecalciferol

• Registration Number: NCT04847947
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study Start: 2021-04-19
• Study First Posted: 2021-04-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Oral capsule Placebo once daily and Calcium Lactate 500 mg once daily for 12 weeks.
Interventional group	Cholecalciferol	Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Vitamin D receptor (VDR) monocyte level	12 weeks	Change from baseline in VDR monocyte level. Measurement : flowcytometry
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
Serum IGF-1 level	12 weeks	change from baseline in serum IGF-1 level. Measurement : ELISA
serum IL-6 level	12 weeks	change from baseline in serum IL-6 level. Measurement : ELISA
Fall incidence	12 weeks	number of fall
Frailty status	12 weeks	improvement in frailty status

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia