Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585995
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Effectiveness and Safety of Two Vitamin D3 Supplementation Regimens in Adults with Early-stage COVID-19
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness and Safety of Two Vitamin D3 Supplementation Regimens in Adults with Early-stage COVID-19
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VDCOVID19ACUTE
Brief Summary:
This study aimed to determine the effectiveness and safety of individualized vitamin D3 supplementation in adult patients with early-stage severe COVID-19 The goal was to see if vitamin D3 could reduce the risk of progressing to critical COVID-19 characterized by severe respiratory distress and other life-threatening complications The research question was What is the effect of vitamin D3 on serum calcidiol levels during the active phase of the disease in adult patients with COVID-19
The study hypothesized that an accelerated vitamin D3 supplementation regimen in adult patients with COVID-19 would achieve the ideal serum calcidiol level 40-60 ngml during the active phase of the disease This was a randomized controlled clinical trial with two parallel groups The first group the accelerated supplementation group received a single monthly dose of vitamin D3 while the second group the daily supplementation group received a daily dose of vitamin D3 during their hospital stay A total of 216 patients were included in the study and were randomly assigned to one of the two groups
Key procedures and measurements included the collection of three blood samples from each patient during their hospital stay-at admission day 1 on day 7 and on day 14 Biomarker analysis measured serum levels of vitamin D3 Von Willebrand Factor interleukin-6 IL-6 and glutathione peroxidase Clinical monitoring was conducted to track the development of critical COVID-19 the need for mechanical ventilation and overall clinical outcomes such as recovery or death
The importance of this study lay in the role of vitamin D3 in immune regulation as it had been identified as a protective factor against severe respiratory infections By determining the optimal supplementation strategy this study hoped to improve clinical outcomes for COVID-19 patients reduce mortality rates and prevent the progression to critical illness
Inclusion criteria for the study were adult patients aged 18-65 years with early-stage severe COVID-19 who had signed informed consent and had no contraindications for vitamin D3 supplementation Exclusion criteria included patients with other severe comorbidities those who were pregnant those requiring immediate intensive care and patients with a history of conditions that affect vitamin D metabolism
Safety and efficacy monitoring tracked the vitamin D3 levels and correlated them with inflammation markers oxidative stress and thrombotic status to evaluate the impact of supplementation Clinical progression was also monitored to assess the safety and efficacy of the vitamin D3 regimens
Outcome measures included changes in serum calcidiol levels correlation of calcidiol levels with biomarkers IL-6 glutathione peroxidase Von Willebrand Factor duration and intensity of COVID-19 symptoms incidence of critical COVID-19 need for mechanical ventilation and overall clinical outcomes recovery or death This study aimed to provide valuable insights into the role of vitamin D3 in managing severe COVID-19 potentially informing treatment guidelines and improving patient outcomes
The study hypothesized that an accelerated vitamin D3 supplementation regimen in adult patients with COVID-19 would achieve the ideal serum calcidiol level 40-60 ngml during the active phase of the disease This was a randomized controlled clinical trial with two parallel groups The first group the accelerated supplementation group received a single monthly dose of vitamin D3 while the second group the daily supplementation group received a daily dose of vitamin D3 during their hospital stay A total of 216 patients were included in the study and were randomly assigned to one of the two groups
Key procedures and measurements included the collection of three blood samples from each patient during their hospital stay-at admission day 1 on day 7 and on day 14 Biomarker analysis measured serum levels of vitamin D3 Von Willebrand Factor interleukin-6 IL-6 and glutathione peroxidase Clinical monitoring was conducted to track the development of critical COVID-19 the need for mechanical ventilation and overall clinical outcomes such as recovery or death
The importance of this study lay in the role of vitamin D3 in immune regulation as it had been identified as a protective factor against severe respiratory infections By determining the optimal supplementation strategy this study hoped to improve clinical outcomes for COVID-19 patients reduce mortality rates and prevent the progression to critical illness
Inclusion criteria for the study were adult patients aged 18-65 years with early-stage severe COVID-19 who had signed informed consent and had no contraindications for vitamin D3 supplementation Exclusion criteria included patients with other severe comorbidities those who were pregnant those requiring immediate intensive care and patients with a history of conditions that affect vitamin D metabolism
Safety and efficacy monitoring tracked the vitamin D3 levels and correlated them with inflammation markers oxidative stress and thrombotic status to evaluate the impact of supplementation Clinical progression was also monitored to assess the safety and efficacy of the vitamin D3 regimens
Outcome measures included changes in serum calcidiol levels correlation of calcidiol levels with biomarkers IL-6 glutathione peroxidase Von Willebrand Factor duration and intensity of COVID-19 symptoms incidence of critical COVID-19 need for mechanical ventilation and overall clinical outcomes recovery or death This study aimed to provide valuable insights into the role of vitamin D3 in managing severe COVID-19 potentially informing treatment guidelines and improving patient outcomes
Detailed Description:
This randomized controlled clinical trial was designed to evaluate the effectiveness and safety of two vitamin D3 supplementation regimens in adult patients with early-stage severe COVID-19 The primary objective was to determine if vitamin D3 could help achieve optimal serum calcidiol levels 40-60 ngml and reduce the risk of progressing to critical COVID-19
The study included 216 adult patients who were diagnosed with early-stage severe COVID-19 Patients were randomly assigned to one of two groups The first group the accelerated supplementation group received a single monthly dose of vitamin D3 while the second group the daily supplementation group received a daily dose of vitamin D3 during their hospital stay
Each patient had three blood samples taken during their hospital stay to monitor the effects of vitamin D3 supplementation The blood samples were collected at admission day 1 on day 7 and on day 14 Each sample consisted of 7 ml of blood with 25 ml used for serum analysis and 45 ml for plasma analysis Biomarker measurements included serum levels of vitamin D3 Von Willebrand Factor interleukin-6 IL-6 and glutathione peroxidase These biomarkers were measured using ELISA kits and analyzed via spectrophotometry The vitamin D3 levels were quantified using the Vitros 5600 analyzer The initial vitamin D3 measurement guided the calculation of the required dose for each patient
Patients were closely monitored for the development of critical COVID-19 defined by severe respiratory distress requiring intensive care Clinical monitoring included tracking the need for mechanical ventilation defined by parameters such as PaO2 60 mmHg SpO2 88 and PaCO2 50 mmHg with pH 732 The overall clinical outcomes including recovery or death were recorded Any adverse events related to vitamin D3 supplementation were documented
Clinical and laboratory data were collected systematically Clinical data were gathered through collaboration with treating physicians and included detailed records of patient progression Laboratory data were obtained from the hospitals pathology laboratory and stored securely The blood samples were processed and stored in a biosecure environment with serum and plasma components separated and stored in an ultracold freezer at -70C until analysis
Inclusion criteria for the study were adult patients aged 18-65 years with early-stage severe COVID-19 who had signed informed consent and had no contraindications for vitamin D3 supplementation Exclusion criteria included patients with severe comorbidities such as terminal cancer or decompensated diabetes pregnant or lactating women patients requiring immediate intensive care and patients with a history of conditions affecting vitamin D metabolism Other exclusion criteria were recent use of high-dose vitamin D3 supplements known intolerance to vitamin D3 and several other medical conditions that could interfere with the study
Safety and efficacy were assessed by tracking serum vitamin D3 levels and correlating them with key biomarkers inflammation measured by IL-6 levels oxidative stress measured by glutathione peroxidase activity and thrombotic status measured by Von Willebrand Factor levels Clinical outcomes and any adverse events were recorded throughout the study to determine whether vitamin D3 supplementation could positively influence these biomarkers and clinical outcomes
The collected data were analyzed using a variety of statistical methods to ensure robustness Descriptive statistics were used to summarize the data including measures of central tendency means medians and dispersion standard deviations ranges The distribution of continuous variables was analyzed using Kolmogorov-Smirnov or Shapiro Wilks tests to assess the normality of the data Pearson or Spearman correlation tests were used to evaluate the relationships between vitamin D3 levels and other biomarkers Chi-square tests and T-tests or Mann-Whitney tests were used to compare proportions and means between the two groups Survival analysis was performed using Kaplan-Meier curves and Cox proportional hazards models to assess the impact of biomarkers on patient survival All statistical analyses were conducted with a significance level of p 005 using PRISM v90 software
Primary outcome measures included changes in serum calcidiol levels correlations with biomarkers IL-6 glutathione peroxidase Von Willebrand Factor and the duration and intensity of COVID-19 symptoms Secondary outcome measures included the incidence of critical COVID-19 the need for mechanical ventilation and overall clinical outcomes recovery or death
The study aimed to provide valuable insights into the role of vitamin D3 in managing severe COVID-19 By comparing two supplementation regimens the study sought to identify the most effective strategy for achieving optimal vitamin D3 levels and improving patient outcomes The findings could inform treatment guidelines and contribute to better clinical management of COVID-19 potentially reducing mortality rates and preventing the progression to critical illness
The study included 216 adult patients who were diagnosed with early-stage severe COVID-19 Patients were randomly assigned to one of two groups The first group the accelerated supplementation group received a single monthly dose of vitamin D3 while the second group the daily supplementation group received a daily dose of vitamin D3 during their hospital stay
Each patient had three blood samples taken during their hospital stay to monitor the effects of vitamin D3 supplementation The blood samples were collected at admission day 1 on day 7 and on day 14 Each sample consisted of 7 ml of blood with 25 ml used for serum analysis and 45 ml for plasma analysis Biomarker measurements included serum levels of vitamin D3 Von Willebrand Factor interleukin-6 IL-6 and glutathione peroxidase These biomarkers were measured using ELISA kits and analyzed via spectrophotometry The vitamin D3 levels were quantified using the Vitros 5600 analyzer The initial vitamin D3 measurement guided the calculation of the required dose for each patient
Patients were closely monitored for the development of critical COVID-19 defined by severe respiratory distress requiring intensive care Clinical monitoring included tracking the need for mechanical ventilation defined by parameters such as PaO2 60 mmHg SpO2 88 and PaCO2 50 mmHg with pH 732 The overall clinical outcomes including recovery or death were recorded Any adverse events related to vitamin D3 supplementation were documented
Clinical and laboratory data were collected systematically Clinical data were gathered through collaboration with treating physicians and included detailed records of patient progression Laboratory data were obtained from the hospitals pathology laboratory and stored securely The blood samples were processed and stored in a biosecure environment with serum and plasma components separated and stored in an ultracold freezer at -70C until analysis
Inclusion criteria for the study were adult patients aged 18-65 years with early-stage severe COVID-19 who had signed informed consent and had no contraindications for vitamin D3 supplementation Exclusion criteria included patients with severe comorbidities such as terminal cancer or decompensated diabetes pregnant or lactating women patients requiring immediate intensive care and patients with a history of conditions affecting vitamin D metabolism Other exclusion criteria were recent use of high-dose vitamin D3 supplements known intolerance to vitamin D3 and several other medical conditions that could interfere with the study
Safety and efficacy were assessed by tracking serum vitamin D3 levels and correlating them with key biomarkers inflammation measured by IL-6 levels oxidative stress measured by glutathione peroxidase activity and thrombotic status measured by Von Willebrand Factor levels Clinical outcomes and any adverse events were recorded throughout the study to determine whether vitamin D3 supplementation could positively influence these biomarkers and clinical outcomes
The collected data were analyzed using a variety of statistical methods to ensure robustness Descriptive statistics were used to summarize the data including measures of central tendency means medians and dispersion standard deviations ranges The distribution of continuous variables was analyzed using Kolmogorov-Smirnov or Shapiro Wilks tests to assess the normality of the data Pearson or Spearman correlation tests were used to evaluate the relationships between vitamin D3 levels and other biomarkers Chi-square tests and T-tests or Mann-Whitney tests were used to compare proportions and means between the two groups Survival analysis was performed using Kaplan-Meier curves and Cox proportional hazards models to assess the impact of biomarkers on patient survival All statistical analyses were conducted with a significance level of p 005 using PRISM v90 software
Primary outcome measures included changes in serum calcidiol levels correlations with biomarkers IL-6 glutathione peroxidase Von Willebrand Factor and the duration and intensity of COVID-19 symptoms Secondary outcome measures included the incidence of critical COVID-19 the need for mechanical ventilation and overall clinical outcomes recovery or death
The study aimed to provide valuable insights into the role of vitamin D3 in managing severe COVID-19 By comparing two supplementation regimens the study sought to identify the most effective strategy for achieving optimal vitamin D3 levels and improving patient outcomes The findings could inform treatment guidelines and contribute to better clinical management of COVID-19 potentially reducing mortality rates and preventing the progression to critical illness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None