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

September 21, 2017 updated by: Aulia Rizka, Indonesia University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elderly age more than 60
  • Willing to join research

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alfacalcidol
Alfacalcidol 0,5 mcg once daily for 90 days
Drug: Alfacalcidol
alfacalcidol 0,5 mcg
Other Names:
  • 1 alpha hydroxy cholecalciferol
Placebo Comparator: Placebo
Amylum same capsule form, weight and colour with treatment arm
Drug: Alfacalcidol
alfacalcidol 0,5 mcg
Other Names:
  • 1 alpha hydroxy cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
upper respiratory tract infection incidence
Time Frame: 90 days
incidence of URTI
90 days
lower respiratory tract infection incidence
Time Frame: 90 days
incidence of LRTI
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Aulia Rizka, MD, Universitas Indonesia / Cipto Mangunkusumo Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2017

Primary Completion (Anticipated)

October 10, 2017

Study Completion (Anticipated)

December 15, 2017

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitaminDIndonesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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