The Effect of Cholecalciferol in Pre-frail Elderly

Indonesia University (Other)
Overall Status
Recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Anticipated Enrollment :
120 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
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
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Handgrip strength [12 weeks (evaluation every 4 weeks)]

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

    2. Gait speed [12 weeks (evaluation every 4 weeks)]

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

    Secondary Outcome Measures

    1. Vitamin D receptor (VDR) monocyte level [12 weeks]

      Change from baseline in VDR monocyte level. Measurement : flowcytometry

    2. Interleukine 6 (IL-6) monocyte level [12 weeks]

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

    3. Insulin Growth Factor-1 (IGF-1) monocyte level [12 weeks]

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

    4. serum VDR level [12 weeks]

      change from baseline in serum VDR level. Measurement : ELISA

    5. Serum IGF-1 level [12 weeks]

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

    6. serum IL-6 level [12 weeks]

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

    7. Fall incidence [12 weeks]

      number of fall

    8. Frailty status [12 weeks]

      improvement in frailty status

    Eligibility Criteria


    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 Cipto Mangunkusumo General Hospital Jakarta DKI Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Indonesia University


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

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    dr. Noto Dwimartutie, , SpPD-KGer, Indonesia University Identifier:
    Other Study ID Numbers:
    • 72/UN2.F1/ETIK/PPM.00.02/2021
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by dr. Noto Dwimartutie, , SpPD-KGer, Indonesia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 25, 2021