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

University of Indonesia (UI)

Status and phase: Unknown; Phase 4

Conditions: Elderly Infection; Frail Elderly Syndrome

Treatments: Drug: Alfacalcidol

Study type: Interventional

Funder types: Other

Identifiers

NCT03292744

VitaminDIndonesia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Elderly age more than 60
• Willing to join research

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

110 participants in 2 patient groups, including a placebo group

Alfacalcidol

Experimental group

Description:

Alfacalcidol 0,5 mcg once daily for 90 days

Treatment:

Drug: Alfacalcidol

Placebo

Placebo Comparator group

Description:

Amylum same capsule form, weight and colour with treatment arm

Treatment:

Drug: Alfacalcidol