The Effect of Cholecalciferol in Pre-frail Elderly
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
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:
|
| 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
- Handgrip strength [12 weeks (evaluation every 4 weeks)]
Change from baseline in handgrip strength. Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer )
- Gait speed [12 weeks (evaluation every 4 weeks)]
Change from baseline in gait speed. Measurement: 15-feet walking test
Secondary Outcome Measures
- Vitamin D receptor (VDR) monocyte level [12 weeks]
Change from baseline in VDR monocyte level. Measurement : flowcytometry
- Interleukine 6 (IL-6) monocyte level [12 weeks]
Change from baseline in IL-6 monocyte level. Measurement : flowcytometry
- Insulin Growth Factor-1 (IGF-1) monocyte level [12 weeks]
Change from baseline in IGF-1 monocyte level. Measurement : flowcytometry
- serum VDR level [12 weeks]
change from baseline in serum VDR level. Measurement : ELISA
- Serum IGF-1 level [12 weeks]
change from baseline in serum IGF-1 level. Measurement : ELISA
- serum IL-6 level [12 weeks]
change from baseline in serum IL-6 level. Measurement : ELISA
- Fall incidence [12 weeks]
number of fall
- Frailty status [12 weeks]
improvement in frailty status
Eligibility Criteria
Criteria
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)
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Unwilling to stop using drug contain vitamin D or vitamin D analog or calcium
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Using steroid or NSAID routinely
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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
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Using drug that can affect vitamin D absorption, eg. bile acid sequestrants
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Cognitive impairment (Abbreviated Mental Test score < 8)
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Depression (Geriatric Depression Scale score > = 10)
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Unwilling to join the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cipto Mangunkusumo General Hospital | Jakarta | DKI Jakarta | Indonesia | 10430 |
Sponsors and Collaborators
- Indonesia University
Investigators
- 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
Publications
- 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.
- 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.
- 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.
- 72/UN2.F1/ETIK/PPM.00.02/2021