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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03292744

Enrollment

110

Registered

2017-09-26

Start date

2017-01-10

Completion date

2017-12-15

Last updated

2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frail Elderly Syndrome, Elderly Infection

Keywords

immunosenescence

Brief summary

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

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.

Interventions

DRUGAlfacalcidol

alfacalcidol 0,5 mcg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Elderly age more than 60 * Willing to join research

Exclusion criteria

* In acute infection * Using NSAID or steroid * Liver failure * Hypercalcemia

Design outcomes

Primary

Measure	Time frame	Description
upper respiratory tract infection incidence	90 days	incidence of URTI
lower respiratory tract infection incidence	90 days	incidence of LRTI

Secondary

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

Countries

Indonesia

Contacts

Primary ContactAulia Rizka, MD

dr.auliarizka@yahoo.co.id+628125265600

Backup ContactAulia Rizka, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026