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

NCT ID: NCT03292744

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2017-12-15

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.

Conditions

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Frail Elderly Syndrome Elderly Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Alfacalcidol

Alfacalcidol 0,5 mcg once daily for 90 days

Group Type EXPERIMENTAL

Alfacalcidol

Intervention Type DRUG

alfacalcidol 0,5 mcg

Placebo

Amylum same capsule form, weight and colour with treatment arm

Group Type PLACEBO_COMPARATOR

Alfacalcidol

Intervention Type DRUG

alfacalcidol 0,5 mcg

Interventions

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Alfacalcidol

alfacalcidol 0,5 mcg

Intervention Type DRUG

Other Intervention Names

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1 alpha hydroxy cholecalciferol

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Aulia Rizka

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aulia Rizka, MD

Role: PRINCIPAL_INVESTIGATOR

Universitas Indonesia / Cipto Mangunkusumo Hospital

Locations

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Cipto Mangunkusumo National Hospital

Jakarta, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Aulia Rizka, MD

Role: CONTACT

[email protected]
+628125265600

Aulia Rizka, MD

Role: CONTACT

Facility Contacts

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Aulia Rizka, MD

Role: primary

[email protected]
+628125265600

Other Identifiers

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VitaminDIndonesia

Identifier Type: -

Identifier Source: org_study_id