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

Frail Elderly Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03292744
• Other study ID #: VitaminDIndonesia
• Status: Recruiting
• Phase: Phase 4
• First received: September 21, 2017
• Last updated: September 21, 2017
• Start date: January 10, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: September 2017
• Source: Indonesia University
• Contact: Aulia Rizka, MD
• Phone: +628125265600
• Email: dr.auliarizka[@]yahoo.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 15, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Elderly age more than 60

• Willing to join research

Exclusion Criteria:

• In acute infection

• Using NSAID or steroid

• Liver failure

• Hypercalcemia

Related Conditions & MeSH terms

• Communicable Diseases
• Elderly Infection
• Frail Elderly Syndrome
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• Alfacalcidol
alfacalcidol 0,5 mcg

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	upper respiratory tract infection incidence	incidence of URTI	90 days
Primary	lower respiratory tract infection incidence	incidence of LRTI	90 days
Secondary	inflammatory markers	IL6, IL10 and IFN gamma in PBMC	day 90
Secondary	T cell subset	CD4/CD8 ratio, CD8+ CD28- percentage	day 90
Secondary	antibiotic use	any antibiotic prescribed by physician	90 days