COVID-19VDCOVID19ACUTENCT06585995
Effectiveness and Safety of Two Vitamin D3 Supplementation Regimens in Adults with Early-stage COVID-19
A study testing vitamin D (cholecalciferol) supplementation in people with COVID-19, run by Escuela Militar de Graduados de Sanidad, SEDENA at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19
- What is being tested?
- vitamin D (cholecalciferol) supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteMexico
- Study dates
- 29 Apr 2022to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients hospitalized for severe COVID-19 clinical presentation in the "early stage," with a maximum of 9 days after the onset of the first symptoms and who have not progressed to the "active phase" (fever, cough, sore throat, diarrhea, loss of taste or smell, oxygen saturation <92%, PaO2 / FiO2 <300 mmHg, respiratory rate >30 breaths per minute, or pulmonary infiltrates >50%).
- Patients older than 18 years and younger than 65 years who have received at least 2 doses of the COVID-19 vaccine.
- Patients who agree to participate at the time of hospitalization and sign the informed consent.
- Patients with 25(OH)D levels below 40 ng/ml and without contraindications for Vitamin D3 supplementation.
Who cannot join
- Patients who, at the time of recruitment, have another comorbidity as the primary condition for which they were hospitalized and that places them at high risk of death (e.g., terminal cancer, postoperative patients, renal failure, liver disease, uncontrolled diabetes, patients with HIV, CMV, tuberculosis, traumatic brain injury, shock from any cause, etc.).
- Pregnant or breastfeeding patients.
- Patients who have received Vitamin D3 supplements greater than 800 IU/day, 15 days before recruitment.
- Patients with contraindications for Vitamin D3 supplementation, such as active granulomatous diseases (sarcoidosis, tuberculosis, lymphoma, Vitamin D3 metabolism disorders, hypercalcemia).
- History of kidney stones.
- Known Vitamin D3 hypervitaminosis or hypercalcemia.
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- Known intolerance to Vitamin D3.
- Patients with extrapulmonary organ failure.
- Patients with 25(OH)D levels equal to or greater than 40 ng/ml.
- Patients who, at the time of recruitment, exhibit clear signs of "critical illness" due to COVID-19, such as organ failure requiring intensive care admission or who meet the criteria for mechanical ventilation due to oxygen desaturation: PaO2 <60 mmHg (after supplemental oxygen), SpO2 <88% (after supplemental oxygen), PaCO2 >50 mmHg with pH <7.32.
- Elimination Criteria:
- Patients who require major surgery after recruitment.
- Patients who develop contraindications to standard COVID-19 treatment.
- Patients who die before completing the three blood sample collections.
- Patients who receive an IL-6 blocking drug.
- Patients who develop clinical conditions that prevent blood sample collection or for whom medical recommendations advise against blood sample collection.
- Patients who withdraw their consent to continue participating in the study.
- Patients who develop adverse reactions secondary to Vitamin D3 administration, requiring the suspension of Vitamin D3, such as severe hypercalcemia.
Trial locations and contacts
1 site in 1 country.
About this study
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 ng/ml) 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.
Read more
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.
Read the 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 ng/ml) 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 2.5 ml used for serum analysis and 4.5 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 <7.32. 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 hospital's 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 -70°C 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 < 0.05, using PRISM v9.0 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.
- Conditions
- COVID-19
- Being tested
- vitamin D (cholecalciferol) supplementation
- Keywords
- COVID-19, Cholecalciferol, Vitamin D, Interleukin-6, Glutathione peroxidase, Cough, dyspnea, fatigue, anxiety, depression
- Medical subject headings
- COVID-19, Cough, Dyspnea, Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D (cholecalciferol) supplementationDrug
This pilot clinical study administered and compared daily and bolus vitamin D dosing regimens to achieve and maintain optimal serum 25(OH)D levels in patients with COVID-19. The daily dose group received constant cholecalciferol supplementation (vitamin D supplementation), aimed at achieving more stable and non-peak 25(OH)D levels. In contrast, the bolus group received a one-month cumulative monthly dose, divided into 4 doses, administered on 4 consecutive days, which could result in rapid increases followed by gradual decreases in 25(OH)D levels. The daily dose of cholecalciferol was calculated using the following formula: Daily dose of cholecalciferol = [Weight (kg) × desired increase in 25(OH)D (ng/ml) × 2.5] - 10 .
Bolus dose = (daily dose)(30 days)/4 doses
| Study group | Role | What they receive |
|---|---|---|
| Daily Vitamin D Supplementation Group | Experimental | This arm of the study involves daily administration of vitamin D to participants, with the dosage adjusted based on body weight and initial vitamin D levels, aiming to to investigate the efficacy of this regimen in improving vitamin D levels and reducing COVID-19 symptoms and IL-6, GPx and Von Willebrand Factor concentration. Receives: Drug: vitamin D (cholecalciferol) supplementation |
| Monthly Bolus Vitamin D Supplementation Group | Experimental | This arm of the study consists of administering a monthly bolus dose of vitamin D, equivalent to the total daily dose accumulated over the month, divided into 4 daily doses on 4 consecutive days, to investigate the efficacy of this regimen in improving vitamin D levels and reducing COVID-19 symptoms and IL-6, GPx and Von Willebrand Factor concentration. Receives: Drug: vitamin D (cholecalciferol) supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutathione Peroxidase (GPx) Activity
This measure evaluates the amount of glutathione peroxidase, such determination is performed by determining the glutathione peroxidase enzyme activity in the plasma of each patient, this parameter is determined with a special glutathione peroxidase enzyme activity determination kit, which indicates the bodys ability to reduce systemic oxidative stress. An increase in GPx activity is expected as a result of vitamin D supplementation.
Measured: Baseline before supplementation, seven days and fourteen days after supplementation
Serum 25-Hydroxyvitamin D Levels
Vitamin D (calcidiol ) will be measured in each sample taken from each of the patients, this measurement will be performed by the clinical laboratory of the hospital center. This measurement will confirm the efficacy of the vitamin D supplementation regimen in achieving and maintaining sufficient serum vitamin D levels, the unit of measurement is nanograms/milliliters.
Measured: Baseline before supplementation, seven days and fourteen days after supplementation
Serum Levels of Interleukin-6 (IL-6)
Interleukin-6 will be quantified in the serum of each patients sample using the ELISA technique. IL-6 is a proinflammatory cytokine. The study aims to observe changes in IL-6 levels, which could be significantly altered by vitamin D supplementation according to preliminary results.
Measured: Baseline before supplementation, seven days and fourteen days after supplementation
Secondary outcomes (2)
Intensity of headache
This measure will determine the intensity of the headache. And it will determine whether there is a significant association between vitamin D supplementation regimen and headache intensity.
Measured: Baseline before supplementation, seven days and fourteen days after supplementation
Duration of fever in days
This measure will determine the duration (in days) of fever in each patient, this determination will be made by asking the patient if according to the body temperature in each day he/she presented or no longer presented a temperature higher than 38 degrees centigrade, the measurement will be made with a conventional thermometer. a sum of the days in which he/she did present fever (temperature higher than 38 degrees centigrade) will be made. Subsequently, this information will be used to determine whether there is a significant association between the vitamin D supplementation regimen and the duration of fever in days.
Measured: Baseline before supplementation, seven days and fourteen days after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start29 Apr 2022
- Primary completion28 Mar 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escuela Militar de Graduados de Sanidad, SEDENA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IVÁN IGNACIO MEJÍA, Escuela Militar de Graduados de Sanidad, SEDENA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585995
- Sponsor's protocol ID
- No. 2022/C-015
- Other IDs
- No. 2022/C-015
- Acronym
- VDCOVID19ACUTE
- Status last verified
- Sep 2024
- First submitted
- 21 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Two Vitamin D3 Supplementation Regimens in Adults with Early-stage COVID-19
- ClinicalTrials.gov ID
- NCT06585995
- Acronym / sponsor ID
- VDCOVID19ACUTE / No. 2022/C-015
- Conditions
- COVID-19
- Keywords
- COVID-19, Cholecalciferol, Vitamin D, Interleukin-6, Glutathione peroxidase, Cough, dyspnea, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Escuela Militar de Graduados de Sanidad, SEDENAUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ng/ml) 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 ng/ml) 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 2.5 ml used for serum analysis and 4.5 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 <7.32. 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 hospital's 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 -70°C 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 < 0.05, using PRISM v9.0 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Vitamin D Supplementation Group | Experimental | Drug: vitamin D (cholecalciferol) supplementationThis arm of the study involves daily administration of vitamin D to participants, with the dosage adjusted based on body weight and initial vitamin D levels, aiming to to investigate the efficacy of this regimen in improving vitamin D levels and reducing COVID-19 symptoms and IL-6, GPx and Von Willebrand Factor concentration. |
| Monthly Bolus Vitamin D Supplementation Group | Experimental | Drug: vitamin D (cholecalciferol) supplementationThis arm of the study consists of administering a monthly bolus dose of vitamin D, equivalent to the total daily dose accumulated over the month, divided into 4 daily doses on 4 consecutive days, to investigate the efficacy of this regimen in improving vitamin D levels and reducing COVID-19 symptoms and IL-6, GPx and Von Willebrand Factor concentration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients hospitalized for severe COVID-19 clinical presentation in the "early stage," with a maximum of 9 days after the onset of the first symptoms and who have not progressed to the "active phase" (fever, cough, sore throat, diarrhea, loss of taste or smell, oxygen saturation <92%, PaO2 / FiO2 <300 mmHg, respiratory rate >30 breaths per minute, or pulmonary infiltrates >50%).
- Patients older than 18 years and younger than 65 years who have received at least 2 doses of the COVID-19 vaccine.
- Patients who agree to participate at the time of hospitalization and sign the informed consent.
- Patients with 25(OH)D levels below 40 ng/ml and without contraindications for Vitamin D3 supplementation.
Key exclusion criteria (18 listed)
- Patients who, at the time of recruitment, have another comorbidity as the primary condition for which they were hospitalized and that places them at high risk of death (e.g., terminal cancer, postoperative patients, renal failure, liver disease, uncontrolled diabetes, patients with HIV, CMV, tuberculosis, traumatic brain injury, shock from any cause, etc.).
- Pregnant or breastfeeding patients.
- Patients who have received Vitamin D3 supplements greater than 800 IU/day, 15 days before recruitment.
- Patients with contraindications for Vitamin D3 supplementation, such as active granulomatous diseases (sarcoidosis, tuberculosis, lymphoma, Vitamin D3 metabolism disorders, hypercalcemia).
- History of kidney stones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D (cholecalciferol) supplementationThis pilot clinical study administered and compared daily and bolus vitamin D dosing regimens to achieve and maintain optimal serum 25(OH)D levels in patients with COVID-19. The daily dose group received constant cholecalciferol supplementation (vitamin D supplementation), aimed at achieving more stable and non-peak 25(OH)D levels. In contrast, the bolus group received a one-month cumulative monthly dose, divided into 4 doses, administered on 4 consecutive days, which could result in rapid increases followed by gradual decreases in 25(OH)D levels. The daily dose of cholecalciferol was calculated using the following formula: Daily dose of cholecalciferol = [Weight (kg) × desired increase in 25(OH)D (ng/ml) × 2.5] - 10 . Bolus dose = (daily dose)(30 days)/4 doses | Drug | Daily Vitamin D Supplementation Group, Monthly Bolus Vitamin D Supplementation Group |
Primary outcome
Glutathione Peroxidase (GPx) Activity
Time frame: Baseline before supplementation, seven days and fourteen days after supplementation
This measure evaluates the amount of glutathione peroxidase, such determination is performed by determining the glutathione peroxidase enzyme activity in the plasma of each patient, this parameter is determined with a special glutathione peroxidase enzyme activity determination kit, which indicates the bodys ability to reduce systemic oxidative stress. An increase in GPx activity is expected as a result of vitamin D supplementation.
Serum 25-Hydroxyvitamin D Levels
Time frame: Baseline before supplementation, seven days and fourteen days after supplementation
Vitamin D (calcidiol ) will be measured in each sample taken from each of the patients, this measurement will be performed by the clinical laboratory of the hospital center. This measurement will confirm the efficacy of the vitamin D supplementation regimen in achieving and maintaining sufficient serum vitamin D levels, the unit of measurement is nanograms/milliliters.
Serum Levels of Interleukin-6 (IL-6)
Time frame: Baseline before supplementation, seven days and fourteen days after supplementation
Interleukin-6 will be quantified in the serum of each patients sample using the ELISA technique. IL-6 is a proinflammatory cytokine. The study aims to observe changes in IL-6 levels, which could be significantly altered by vitamin D supplementation according to preliminary results.
2 secondary outcomes
Intensity of headache
Time frame: Baseline before supplementation, seven days and fourteen days after supplementation
Duration of fever in days
Time frame: Baseline before supplementation, seven days and fourteen days after supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D (cholecalciferol) supplementation in people with COVID-19, run by Escuela Militar de Graduados de Sanidad, SEDENA at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutathione Peroxidase (GPx) Activity (time frame: Baseline before supplementation, seven days and fourteen days after supplementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.