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Pre-frail ElderlyPhase 3NCT04847947

The Effect of Cholecalciferol in Pre-frail Elderly

A Phase 3 study testing Cholecalciferol in people with Pre-frail Elderly, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Pre-frail Elderly
What is being tested?
Cholecalciferol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteIndonesia
Study dates
19 Apr 2021to 31 Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre-frail elderly
  • Capable to understand and carry-out the instruction

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo General Hospital

    Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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.

Read the 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.

Being tested
Cholecalciferol, Placebo
Keywords
Frailty, Pre-frail, Elderly, Cholecalciferol, Handgrip strength, Gait speed, Vitamin D receptor, Insulin Growth Factor-1, Interleukin-6
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholecalciferolDrug

    Also called Vitamin D3, Prove D3

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

  • PlaceboDrug

    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

Study groups in NCT04847947
Study groupRoleWhat they receive
Interventional groupExperimentalOral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks.
Receives: Drug: Cholecalciferol
Control GroupPlacebo comparatorOral capsule Placebo once daily and Calcium Lactate 500 mg once daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Handgrip strength

    Change from baseline in handgrip strength. Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer )

    Measured: 12 weeks (evaluation every 4 weeks)

  2. Gait speed

    Change from baseline in gait speed. Measurement: 15-feet walking test

    Measured: 12 weeks (evaluation every 4 weeks)

Secondary outcomes (8)

  1. Vitamin D receptor (VDR) monocyte level

    Change from baseline in VDR monocyte level. Measurement : flowcytometry

    Measured: 12 weeks

  2. Interleukine 6 (IL-6) monocyte level

    Change from baseline in IL-6 monocyte level. Measurement : flowcytometry

    Measured: 12 weeks

  3. Insulin Growth Factor-1 (IGF-1) monocyte level

    Change from baseline in IGF-1 monocyte level. Measurement : flowcytometry

    Measured: 12 weeks

  4. serum VDR level

    change from baseline in serum VDR level. Measurement : ELISA

    Measured: 12 weeks

  5. Serum IGF-1 level

    change from baseline in serum IGF-1 level. Measurement : ELISA

    Measured: 12 weeks

  6. serum IL-6 level

    change from baseline in serum IL-6 level. Measurement : ELISA

    Measured: 12 weeks

  7. Fall incidence

    number of fall

    Measured: 12 weeks

  8. Frailty status

    improvement in frailty status

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start19 Apr 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04847947
Sponsor's protocol ID
72/UN2.F1/ETIK/PPM.00.02/2021
Status last verified
Jan 2023
First submitted
13 Apr 2021
Last updated
26 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Setiati S, Anugrahini, Fransiska JE, Tamin TZ, Istanti R. Combination of alfacalcidol and calcium improved handgrip strength and mobility among Indonesian older women: A randomized controlled trial. Geriatr Gerontol Int. 2018 Mar;18(3):434-440. doi: 10.1111/ggi.13201. Epub 2017 Nov 15.

    PubMed 29143428

  • Bray NW, Doherty TJ, Montero-Odasso M. The Effect of High Dose Vitamin D3 on Physical Performance in Frail Older Adults. A Feasibility Study. J Frailty Aging. 2018;7(3):155-161. doi: 10.14283/jfa.2018.18.

    PubMed 30095145

  • Meireles MS, Kamimura MA, Dalboni MA, Giffoni de Carvalho JT, Aoike DT, Cuppari L. Effect of cholecalciferol on vitamin D-regulatory proteins in monocytes and on inflammatory markers in dialysis patients: A randomized controlled trial. Clin Nutr. 2016 Dec;35(6):1251-1258. doi: 10.1016/j.clnu.2016.04.014. Epub 2016 Apr 26.

    PubMed 27161894

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cholecalciferol in people with Pre-frail Elderly, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Handgrip strength (time frame: 12 weeks (evaluation every 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04847947, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.

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