The Effect of Cholecalciferol in Pre-frail Elderly

January 25, 2023 updated by: dr. Noto Dwimartutie, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto mangunkusumo general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks.
Drug: Cholecalciferol
Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks
Other Names:
  • Vitamin D3
  • Prove D3
Placebo Comparator: Control Group
Oral capsule Placebo once daily and Calcium Lactate 500 mg once daily for 12 weeks.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: 12 weeks (evaluation every 4 weeks)
Change from baseline in handgrip strength. Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer )
12 weeks (evaluation every 4 weeks)
Gait speed
Time Frame: 12 weeks (evaluation every 4 weeks)
Change from baseline in gait speed. Measurement: 15-feet walking test
12 weeks (evaluation every 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D receptor (VDR) monocyte level
Time Frame: 12 weeks
Change from baseline in VDR monocyte level. Measurement : flowcytometry
12 weeks
Interleukine 6 (IL-6) monocyte level
Time Frame: 12 weeks
Change from baseline in IL-6 monocyte level. Measurement : flowcytometry
12 weeks
Insulin Growth Factor-1 (IGF-1) monocyte level
Time Frame: 12 weeks
Change from baseline in IGF-1 monocyte level. Measurement : flowcytometry
12 weeks
serum VDR level
Time Frame: 12 weeks
change from baseline in serum VDR level. Measurement : ELISA
12 weeks
Serum IGF-1 level
Time Frame: 12 weeks
change from baseline in serum IGF-1 level. Measurement : ELISA
12 weeks
serum IL-6 level
Time Frame: 12 weeks
change from baseline in serum IL-6 level. Measurement : ELISA
12 weeks
Fall incidence
Time Frame: 12 weeks
number of fall
12 weeks
Frailty status
Time Frame: 12 weeks
improvement in frailty status
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Noto Dwimartutie, MD, SpPD-KGer, Division of Geriatric, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia, Cipto Mangunkusumo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72/UN2.F1/ETIK/PPM.00.02/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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