Effect of Alfacalcidol to Respiratory Infection and Immun... | NCT03292744

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

NCT03292744

Sponsor

Indonesia University

Status

Unknown status

Last Update Posted

Sep 26, 2017Actual

Enrollment

110Estimated

Phase

Phase 4

Conditions

Frail Elderly Syndrome
Elderly Infection

Interventions

Alfacalcidol

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2017Actual

Primary Completion Date

Oct 10, 2017Estimated

Completion Date

Dec 15, 2017Estimated

First Submitted Date

Sep 21, 2017

First Submission Date that Met QC Criteria

Sep 21, 2017

First Posted Date

Sep 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2017

Last Update Posted Date

Sep 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Alfacalcidol	Drug	alfacalcidol 0,5 mcg	Alfacalcidol Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
inflammatory markers	IL6, IL10 and IFN gamma in PBMC	day 90
T cell subset	CD4/CD8 ratio, CD8+ CD28- percentage	day 90

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aulia Rizka, MD	Contact	+628125265600		dr.auliarizka@yahoo.co.id
Aulia Rizka, MD	Contact

Overall Officials

Name	Affiliation	Role
Aulia Rizka, MD	Universitas Indonesia / Cipto Mangunkusumo Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo National Hospital	Recruiting	Jakarta			Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C008088	alfacalcidol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided