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NCT Number: NCT04847947

The Effect of Cholecalciferol in Pre-frail Elderly

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.

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Key information

Conditions

Pre-frail Elderly Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cipto Mangunkusumo General Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Cholecalciferol

Drug

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

Other names: Vitamin D3, Prove D3

Placebo

Drug

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

Primary outcomes

  1. Handgrip strength

    Time frame: 12 weeks (evaluation every 4 weeks)

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

  2. Gait speed

    Time frame: 12 weeks (evaluation every 4 weeks)

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

Secondary outcomes

  1. Vitamin D receptor (VDR) monocyte level

    Time frame: 12 weeks

    Change from baseline in VDR monocyte level. Measurement : flowcytometry

  2. Interleukine 6 (IL-6) monocyte level

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

  4. serum VDR level

    Time frame: 12 weeks

    change from baseline in serum VDR level. Measurement : ELISA

  5. Serum IGF-1 level

    Time frame: 12 weeks

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

  6. serum IL-6 level

    Time frame: 12 weeks

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

  7. Fall incidence

    Time frame: 12 weeks

    number of fall

  8. Frailty status

    Time frame: 12 weeks

    improvement in frailty status

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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