The Effect of Cholecalciferol in Pre-frail Elderly

NCT04847947 | Completed Phase 3

• 1 other identifier: 72/UN2.F1/ETIK/PPM.00.02/2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-frail Elderly

Keywords

Frailty; Pre-frail; Elderly; Cholecalciferol; Handgrip strength; Gait speed; Vitamin D receptor; Insulin Growth Factor-1; Interleukin-6

Outcome Measures

Primary Outcomes (2)

• Handgrip strength

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

  12 weeks (evaluation every 4 weeks)

• Gait speed

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

  12 weeks (evaluation every 4 weeks)

Secondary Outcomes (8)

• Vitamin D receptor (VDR) monocyte level

  12 weeks

• Interleukine 6 (IL-6) monocyte level

  12 weeks

• Insulin Growth Factor-1 (IGF-1) monocyte level

  12 weeks

• serum VDR level

  12 weeks

• Serum IGF-1 level

  12 weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Drug: Cholecalciferol

Control Group

PLACEBO COMPARATOR

Oral capsule Placebo once daily and Calcium Lactate 500 mg once daily for 12 weeks.

Drug: Placebo

Interventions

Cholecalciferol DRUG

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

Also known as: Vitamin D3, Prove D3

Interventional group

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

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 29143428 BACKGROUND

• 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.

  PMID: 30095145 BACKGROUND

• 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.

  PMID: 27161894 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Noto Dwimartutie, MD, SpPD-KGer

  Division of Geriatric, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia, Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: , SpPD-KGer

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: April 19, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

ID (1)