Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
Sponsor
Universitas Sebelas Maret (Other)
Overall Status
Completed
CT.gov ID
NCT05765617
Collaborator
(none)
16
1
2
3
5.4
Study Details
Study Description
Brief Summary
This research is a study that compares the administration of calcitriol with the outcomes of COVID-19 patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Treatment
Official Title:
Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
Actual Study Start Date
:
Jul 1, 2021
Actual Primary Completion Date
:
Sep 30, 2021
Actual Study Completion Date
:
Sep 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control Placebo 2x1 per day |
Other: Placebo
Placebo give 2x1 per day for five day
|
| Experimental: Calcitriol the treatment group received calcitriol 2x400 iu per day for 5 day |
Drug: Calcitriol
The treatment group received calcitriol 2x400 iu per day for five days. Calcitriol uses Oscal, obtained from Kalbe Pharma
Other Names:
|
Outcome Measures
Primary Outcome Measures
- HsCRP [Hs CRP (high sensitive c reactive protein) examination was carried out on the first day of hospitalization and the 5th day of hospitalization]
High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- COVID-19 patients, hospitalized patients, and patients aged 18-60 years
Exclusion Criteria:
- pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitas Sebelas Maret Hospital | Sukoharjo | Central Java | Indonesia | 57161 |
Sponsors and Collaborators
- Universitas Sebelas Maret
Investigators
- Principal Investigator: Nurhasan Agung Prabowo, MD, Universitas Sebelas Maret
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nurhasan Agung Prabowo,
M.D.,
Universitas Sebelas Maret
ClinicalTrials.gov Identifier:
NCT05765617
Other Study ID Numbers:
- NAP03
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Mar 1, 2023
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
Keywords provided by Nurhasan Agung Prabowo,
M.D.,
Universitas Sebelas Maret
Additional relevant MeSH terms: