The Effect of Cholecalciferol in Pre-frail Elderly

Pre-frail Elderly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847947
• Other study ID #: 72/UN2.F1/ETIK/PPM.00.02/2021
• Status: Completed
• Phase: Phase 3
• Start date: April 19, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-frail Elderly

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handgrip strength	Change from baseline in handgrip strength. Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer )	12 weeks (evaluation every 4 weeks)
Primary	Gait speed	Change from baseline in gait speed. Measurement: 15-feet walking test	12 weeks (evaluation every 4 weeks)
Secondary	Vitamin D receptor (VDR) monocyte level	Change from baseline in VDR monocyte level. Measurement : flowcytometry	12 weeks
Secondary	Interleukine 6 (IL-6) monocyte level	Change from baseline in IL-6 monocyte level. Measurement : flowcytometry	12 weeks
Secondary	Insulin Growth Factor-1 (IGF-1) monocyte level	Change from baseline in IGF-1 monocyte level. Measurement : flowcytometry	12 weeks
Secondary	serum VDR level	change from baseline in serum VDR level. Measurement : ELISA	12 weeks
Secondary	Serum IGF-1 level	change from baseline in serum IGF-1 level. Measurement : ELISA	12 weeks
Secondary	serum IL-6 level	change from baseline in serum IL-6 level. Measurement : ELISA	12 weeks
Secondary	Fall incidence	number of fall	12 weeks
Secondary	Frailty status	improvement in frailty status	12 weeks