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

Phase 4

• Conditions: Elderly Infection; Frail Elderly Syndrome
• Interventions: Drug: Alfacalcidol

• Registration Number: NCT03292744
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2017-01-10
• Status Verified: 2017-09
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-21
• Last Update Submitted: 2017-09-21
• Study First Posted: 2017-09-26
• Last Update Posted: 2017-09-26
• Primary Completion: 2017-10-10
• Study Completion: 2017-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Elderly age more than 60
• Willing to join research

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Alfacalcidol	Amylum same capsule form, weight and colour with treatment arm
Alfacalcidol	Alfacalcidol	Alfacalcidol 0,5 mcg once daily for 90 days

Primary Outcome Measures

Name	Time	Method
upper respiratory tract infection incidence	90 days	incidence of URTI
lower respiratory tract infection incidence	90 days	incidence of LRTI

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cipto Mangunkusumo National Hospital; 🇮🇩 Jakarta, Indonesia