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

Primary Purpose

Frail Elderly Syndrome, Elderly Infection

Status
Unknown status
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Alfacalcidol
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frail Elderly Syndrome focused on measuring immunosenescence

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Cipto Mangunkusumo National HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alfacalcidol

Placebo

Arm Description

Alfacalcidol 0,5 mcg once daily for 90 days

Amylum same capsule form, weight and colour with treatment arm

Outcomes

Primary Outcome Measures

upper respiratory tract infection incidence
incidence of URTI
lower respiratory tract infection incidence
incidence of LRTI

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2017
Last Updated
September 21, 2017
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT03292744
Brief Title
Effect of Alfacalcidol to Respiratory Infection and Immune Response of Indonesian Elderly
Official Title
Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
October 10, 2017 (Anticipated)
Study Completion Date
December 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Elderly Infection
Keywords
immunosenescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alfacalcidol
Arm Type
Experimental
Arm Description
Alfacalcidol 0,5 mcg once daily for 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Amylum same capsule form, weight and colour with treatment arm
Intervention Type
Drug
Intervention Name(s)
Alfacalcidol
Other Intervention Name(s)
1 alpha hydroxy cholecalciferol
Intervention Description
alfacalcidol 0,5 mcg
Primary Outcome Measure Information:
Title
upper respiratory tract infection incidence
Description
incidence of URTI
Time Frame
90 days
Title
lower respiratory tract infection incidence
Description
incidence of LRTI
Time Frame
90 days
Secondary Outcome Measure Information:
Title
inflammatory markers
Description
IL6, IL10 and IFN gamma in PBMC
Time Frame
day 90
Title
T cell subset
Description
CD4/CD8 ratio, CD8+ CD28- percentage
Time Frame
day 90
Title
antibiotic use
Description
any antibiotic prescribed by physician
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elderly age more than 60 Willing to join research Exclusion Criteria: In acute infection Using NSAID or steroid Liver failure Hypercalcemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aulia Rizka, MD
Phone
+628125265600
Email
dr.auliarizka@yahoo.co.id
First Name & Middle Initial & Last Name or Official Title & Degree
Aulia Rizka, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aulia Rizka, MD
Organizational Affiliation
Universitas Indonesia / Cipto Mangunkusumo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo National Hospital
City
Jakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aulia Rizka, MD
Phone
+628125265600
Email
dr.auliarizka@yahoo.co.id

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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