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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03292744
Recruitment Status : Unknown
Verified September 2017 by Aulia Rizka, Indonesia University.
Recruitment status was:  Recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Information provided by (Responsible Party):
Aulia Rizka, Indonesia University

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
Frail Elderly Syndrome Elderly Infection Drug: Alfacalcidol 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 10, 2017
Estimated Primary Completion Date : October 10, 2017
Estimated Study Completion Date : December 15, 2017

Arm Intervention/treatment
Experimental: Alfacalcidol
Alfacalcidol 0,5 mcg once daily for 90 days
Drug: Alfacalcidol
alfacalcidol 0,5 mcg
Other Name: 1 alpha hydroxy cholecalciferol

Placebo Comparator: Placebo
Amylum same capsule form, weight and colour with treatment arm
Drug: Alfacalcidol
alfacalcidol 0,5 mcg
Other Name: 1 alpha hydroxy cholecalciferol

Primary Outcome Measures :
  1. upper respiratory tract infection incidence [ Time Frame: 90 days ]
    incidence of URTI

  2. lower respiratory tract infection incidence [ Time Frame: 90 days ]
    incidence of LRTI

Secondary Outcome Measures :
  1. inflammatory markers [ Time Frame: day 90 ]
    IL6, IL10 and IFN gamma in PBMC

  2. T cell subset [ Time Frame: day 90 ]
    CD4/CD8 ratio, CD8+ CD28- percentage

  3. antibiotic use [ Time Frame: 90 days ]
    any antibiotic prescribed by physician

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03292744

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Contact: Aulia Rizka, MD +628125265600
Contact: Aulia Rizka, MD

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Cipto Mangunkusumo National Hospital Recruiting
Jakarta, Indonesia
Contact: Aulia Rizka, MD    +628125265600   
Sponsors and Collaborators
Indonesia University
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Principal Investigator: Aulia Rizka, MD Universitas Indonesia / Cipto Mangunkusumo Hospital
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Responsible Party: Aulia Rizka, MD, Indonesia University Identifier: NCT03292744    
Other Study ID Numbers: VitaminDIndonesia
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Indonesia University:
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Growth Substances
Bone Density Conservation Agents