Effect of Alfacalcidol to Respiratory Infection and Immune Response of Indonesian Elderly

Study Overview
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Brief Summary
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Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to immune system. In elderly, immune disregulation or immunosenecence have great impact to infection response. This study is aimed to determine the effect of alfacalcidol supplementation in vitro and in vivo to respiratory infection incidence and inflammatory markers, as well as T cell lymphocyte subset in Indonesian elderly patients.

Detailed Description
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This study consist of 2 designs. First is in vitro study to investigate the effect of alfacalcidol supplementation to IL-6, IL-10 and IFN gamma regulation in Peripheral Blood Mononuclear Cells (PBMC) of elderly and second design is randomised controlled trial to evaluate the effect of 3 months supplementation of alfacalcidol 0,5 mcg in respiratory infection, antibiotic use, inflammatory markers, CD4/CD8 ratio and CD8+ CD28+ in Indonesian elderly with various level of frailty syndrome.

Official Title
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Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly

Conditions
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Frail Elderly Syndrome, Elderly Infection

Intervention / Treatment
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* Drug: Alfacalcidol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly age more than 60 Willing to join research Exclusion Criteria: In acute infection Using NSAID or steroid Liver failure Hypercalcemia

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alfacalcidol<br>Alfacalcidol 0,5 mcg once daily for 90 days | Drug: Alfacalcidol<br>* alfacalcidol 0,5 mcg<br>* Other names: 1 alpha hydroxy cholecalciferol;|
| Placebo Comparator: Placebo<br>Amylum same capsule form, weight and colour with treatment arm | Drug: Alfacalcidol<br>* alfacalcidol 0,5 mcg<br>* Other names: 1 alpha hydroxy cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper respiratory tract infection incidence | incidence of URTI | 90 days | 
| lower respiratory tract infection incidence | incidence of LRTI | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers | IL6, IL10 and IFN gamma in PBMC | day 90 | 
| T cell subset | CD4/CD8 ratio, CD8+ CD28- percentage | day 90 | 
| antibiotic use | any antibiotic prescribed by physician | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunosenescence