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Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Calcitriol
Placebo
Sponsored by
Universitas Sebelas Maret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring calcitriol, HsCRP

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: COVID-19 patients, hospitalized patients, and patients aged 18-60 years Exclusion Criteria: pregnancy

Sites / Locations

  • Universitas Sebelas Maret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Calcitriol

Arm Description

Placebo 2x1 per day

the treatment group received calcitriol 2x400 iu per day for 5 day

Outcomes

Primary Outcome Measures

HsCRP
High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation

Secondary Outcome Measures

Full Information

First Posted
March 9, 2023
Last Updated
March 9, 2023
Sponsor
Universitas Sebelas Maret
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1. Study Identification

Unique Protocol Identification Number
NCT05765617
Brief Title
Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
Official Title
Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research is a study that compares the administration of calcitriol with the outcomes of COVID-19 patients
Detailed Description
This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
calcitriol, HsCRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study used calcitriol and a placebo, which were similar in shape; researchers and patients did not know who was getting the drug or placebo.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo 2x1 per day
Arm Title
Calcitriol
Arm Type
Experimental
Arm Description
the treatment group received calcitriol 2x400 iu per day for 5 day
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Oscal
Intervention Description
The treatment group received calcitriol 2x400 iu per day for five days. Calcitriol uses Oscal, obtained from Kalbe Pharma
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo give 2x1 per day for five day
Primary Outcome Measure Information:
Title
HsCRP
Description
High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation
Time Frame
Hs CRP (high sensitive c reactive protein) examination was carried out on the first day of hospitalization and the 5th day of hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COVID-19 patients, hospitalized patients, and patients aged 18-60 years Exclusion Criteria: pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurhasan Agung Prabowo, MD
Organizational Affiliation
Universitas Sebelas Maret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitas Sebelas Maret Hospital
City
Sukoharjo
State/Province
Central Java
ZIP/Postal Code
57161
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients

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