NCT03292744

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

September 21, 2017

Last Update Submit

September 21, 2017

Conditions

Frail Elderly SyndromeElderly Infection

Keywords

immunosenescence

Outcome Measures

Primary Outcomes (2)

  • upper respiratory tract infection incidence

    incidence of URTI

    90 days

  • lower respiratory tract infection incidence

    incidence of LRTI

    90 days

Secondary Outcomes (3)

  • inflammatory markers

    day 90

  • T cell subset

    day 90

  • antibiotic use

    90 days

Study Arms (2)

Alfacalcidol

EXPERIMENTAL

Alfacalcidol 0,5 mcg once daily for 90 days

Drug: Alfacalcidol

Placebo

PLACEBO COMPARATOR

Amylum same capsule form, weight and colour with treatment arm

Drug: Alfacalcidol

Interventions

AlfacalcidolDRUG

alfacalcidol 0,5 mcg

Also known as: 1 alpha hydroxy cholecalciferol
AlfacalcidolPlacebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly age more than 60
  • Willing to join research

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta, Indonesia

RECRUITING

MeSH Terms

Interventions

alfacalcidol

Study Officials

  • Aulia Rizka, MD

    Universitas Indonesia / Cipto Mangunkusumo Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aulia Rizka, MD

CONTACT

+628125265600dr.auliarizka@yahoo.co.id

Aulia Rizka, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 26, 2017

Study Start

January 10, 2017

Primary Completion

October 10, 2017

Study Completion

December 15, 2017

Last Updated

September 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)