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

Sponsor
Indonesia University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03292744
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
11.1
Anticipated Duration (Months)
9.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly
Actual Study Start Date :
Jan 10, 2017
Anticipated Primary Completion Date :
Oct 10, 2017
Anticipated Study Completion Date :
Dec 15, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. upper respiratory tract infection incidence [90 days]

      incidence of URTI

    2. lower respiratory tract infection incidence [90 days]

      incidence of LRTI

    Secondary Outcome Measures

    1. inflammatory markers [day 90]

      IL6, IL10 and IFN gamma in PBMC

    2. T cell subset [day 90]

      CD4/CD8 ratio, CD8+ CD28- percentage

    3. antibiotic use [90 days]

      any antibiotic prescribed by physician

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Elderly age more than 60

    • Willing to join research

    Exclusion Criteria:

    • In acute infection

    • Using NSAID or steroid

    • Liver failure

    • Hypercalcemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cipto Mangunkusumo National Hospital Jakarta Indonesia

    Sponsors and Collaborators

    • Indonesia University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aulia Rizka, MD, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT03292744
    Other Study ID Numbers:
    • VitaminDIndonesia
    First Posted:
    Sep 26, 2017
    Last Update Posted:
    Sep 26, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Aulia Rizka, MD, Indonesia University
    immunosenescence
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections
    Cholecalciferol
    Alfacalcidol
    Hydroxycholecalciferols

    Study Results

    No Results Posted as of Sep 26, 2017