Post-COVID19 ConditionVITDPOSTCOVIDNCT06419712
Effect of Vitamin D Supplementation on Glutathione Peroxidase (GPx) Activity, Interleukin-6 (IL-6) Levels and Clinical Outcomes in Post-COVID-19 Patients
A study testing vitamin D (cholecalciferol) supplementation in people with Post-COVID19 Condition, run by Escuela Militar de Graduados de Sanidad, SEDENA at 1 site in Mexico.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of vitamin D supplementation in treating neuropsychiatric symptoms and improving antioxidant levels in individuals diagnosed with post-COVID-19 condition, a state known as long-COVID. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-COVID19 Condition
- What is being tested?
- vitamin D (cholecalciferol) supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMexico
- Study dates
- 25 Nov 2022to 25 May 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Post-COVID-19 Condition: Patients must have been previously diagnosed with COVID-19 and continue to experience persistent symptoms after recovery.
- Age: Participants must be adults aged 18 years or older.
- Vitamin D Deficiency: Initial serum 25-hydroxyvitamin D levels below 40 ng/mL.
- Completed Hospital Treatment for COVID-19: Patients must have been discharged from hospital treatment for COVID-19 at least 12 months prior to the study.
- Ability to Give Informed Consent: Participants must be capable of understanding and willing to sign a consent form.
- Ability to Perform Required Tests: Participants must be physically able to undergo spirometry and other functional tests as required by the study protocol.
Who cannot join
- Reading and Writing Difficulties: Patients who have difficulties in reading and/or writing that would impede their understanding of the study requirements or communication with study staff.
- Inability to Perform Physical Tests: Patients unable to perform functional walk and spirometry tests.
- Untreated Chronic Non-Respiratory Diseases: Individuals suffering from untreated chronic diseases such as diabetes mellitus, systemic arterial hypertension, hypothyroidism, or epilepsy that could interfere with the study outcomes.
- Recent Use of Vitamin D Supplements: Patients who have taken vitamin D supplements within three months prior to the start of the study.
- Participation in Other Clinical Trials: Patients currently participating in other clinical trials that might conflict with this study's protocol.
- Pregnancy: Due to potential risks and lack of data on high-dose vitamin D supplementation during pregnancy, pregnant women will be excluded.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico City, 14080
About this study
The goal of this clinical trial is to evaluate the effectiveness of vitamin D supplementation in treating neuropsychiatric symptoms and improving antioxidant levels in individuals diagnosed with post-COVID-19 condition, a state known as long-COVID. These individuals are primarily adults who have recovered from severe COVID-19 and exhibit persistent symptoms. The main questions it aims to answer are:
Does vitamin D (cholecalciferol) supplementation decrease levels of anxiety and depression in patients with post-COVID-19 condition? Does vitamin D (cholecalciferol) supplementation increase glutathione peroxidase (GPx) activity in these patients? Researchers will compare the effects of daily versus bolus doses of vitamin D (cholecalciferol) to see if one method is more effective than the other in achieving sufficient vitamin D levels and improving clinical outcomes.
Read more
Participants will:
Be randomly assigned to receive either a daily dose or a bolus dose of vitamin D over an 8-week period.
Undergo blood tests to measure biochemical markers such as interleukin-6 (IL-6) and GPx before and two months after starting supplementation.
Have their lung function tested using spirometry and diffusing capacity for carbon monoxide.
Complete the Hospital Anxiety and Depression Scale to assess changes in anxiety and depression levels.
Read the detailed description
This clinical trial investigates the potential therapeutic benefits of vitamin D supplementation in individuals experiencing persistent health issues following recovery from severe COVID-19, commonly referred to as post-COVID-19 condition or long-COVID. The study primarily focuses on the neuropsychiatric symptoms such as anxiety and depression and the antioxidant enzyme activity, specifically glutathione peroxidase (GPx), which plays a critical role in mitigating oxidative stress within the body.
The trial is designed as a pilot, randomized controlled trial, where participants are divided into two groups to receive vitamin D in different dosing regimens: a daily dose and a bolus dose, administered weekly. This method allows for an examination of the efficacy of dosage frequency on achieving optimal serum vitamin D levels, which are hypothesized to influence the biochemical pathways involved in inflammatory and oxidative processes.
During the study, participants\' serum levels of 25-hydroxyvitamin D (25(OH)D), a marker for vitamin D status, are assessed to ensure they reach and maintain a target level that previous studies have associated with optimal immune function and reduced inflammation. The participants\' initial vitamin D status is carefully evaluated to tailor the supplementation dose according to individual needs, following a formula that considers their weight and the desired increase in 25(OH)D levels.
The antioxidant capacity of participants is measured through the activity of GPx in the blood. This enzyme is crucial for reducing oxidative stress, which is linked to various chronic diseases and has been suggested to play a significant role in the severity and progression of post-COVID-19 symptoms. By measuring GPx activity before and after vitamin D supplementation, the study aims to provide insights into the effectiveness of vitamin D in enhancing antioxidant defenses in post-COVID patients.
Furthermore, the trial includes an evaluation of lung function using high-resolution computed tomography (HRCT) and standard pulmonary function tests, including spirometry and the diffusing capacity of the lung for carbon monoxide (DLCO). These assessments help to determine any improvements in respiratory health, which is often compromised in patients with long-term COVID-19 effects.
The impact of vitamin D on neuropsychiatric symptoms is assessed using the Hospital Anxiety and Depression Scale (HADS), a validated tool that rates the severity of anxiety and depression symptoms. This aspect of the study highlights the potential of vitamin D not just as a physical health supplement but also as a modulator of mental health, particularly in the context of the ongoing recovery from a severe infectious disease.
By conducting this trial, the researchers aim to shed light on the broader implications of vitamin D supplementation, not only as a means of improving vitamin D status but also as a potentially significant intervention for improving the quality of life and health outcomes in individuals suffering from long-term effects of COVID-19.
- Conditions
- Post-COVID19 Condition
- Being tested
- vitamin D (cholecalciferol) supplementation
- Keywords
- Post-COVID-19 condition, long-COVID-19, vitamin D, cholecalciferol, interleukin-6, glutathione peroxidase, cough, dyspnea, fatigue, anxiety, depression
- Medical subject headings
- Post-Acute COVID-19 Syndrome, 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 clinical pilot study administered and compared daily and bolus dosing regi-mens of vitamin D to achieve and maintain optimal serum levels of 25(OH)D in post-COVID patients. The daily dose group received constant and gradual supplementation of cholecalciferol, intended to achieve more stable 25(OH)D levels without peaks. Conversely, the bolus group received a weekly dose that could lead to rapid increases followed by gradual declines 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 .
| 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 achieve and maintain optimal serum vitamin D levels Receives: Drug: vitamin D (cholecalciferol) supplementation |
| Weekly Bolus Vitamin D Supplementation Group | Experimental | This arm of the study involves administering a weekly bolus dose of vitamin D, equivalent to the total daily dose accumulated over the week, to investigate the efficacy of this regimen in improving vitamin D levels and reducing post-COVID-19 symptoms. 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 assesses the antioxidant enzyme activity level in the blood, indicating the body's capacity to reduce oxidative stress. Increased activity of GPx is expected as a result of vitamin D supplementation
Measured: Baseline and two months post-supplementation
Serum Levels of Interleukin-6 (IL-6)
IL-6 is a pro-inflammatory cytokine. The study aims to observe changes in IL-6 levels, which might not be significantly altered by vitamin D supplementation as per preliminary findings.
Measured: Baseline and two months post-supplementation.
Secondary outcomes (2)
Lung Function Tests
Includes Forced Vital Capacity (FVC) and Forced Expiratory Volume in One Second (FEV1). Improvements in these parameters would suggest beneficial effects of vitamin D on lung health
Measured: Baseline and two months post-supplementation.
Neuropsychiatric Symptoms (Anxiety and Depression)
The severity of anxiety and depression will be quantified using the Hospital Anxiety and Depression Scale (HADS). A decrease in HADS scores post-supplementation is anticipated.
Measured: Baseline and two months post-supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start25 Nov 2022
- Primary completion20 Apr 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID19 ConditionStudies 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
- 54 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
- NCT06419712
- Sponsor's protocol ID
- C32-22
- Acronym
- VITDPOSTCOVID
- Status last verified
- Jan 2025
- First submitted
- 15 May 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study, and after publication of the primary findings, the following Individual Participant Data will be made available: Anonymized Participant Data: This includes all individual data collected during the trial, minus any personally identifiable information. Data types include: Demographic information (age, gender, etc.) Clinical data (symptoms, disease severity, etc.) Treatment data (dosage received, treatment duration, etc.) Outcome data (response to treatment, side effects, etc.) Laboratory results (vitamin D levels, IL-6 levels, GPx activity, etc.).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Glutathione Peroxidase (GPx) Activity, Interleukin-6 (IL-6) Levels and Clinical Outcomes in Post-COVID-19 Patients
- ClinicalTrials.gov ID
- NCT06419712
- Acronym / sponsor ID
- VITDPOSTCOVID / C32-22
- Conditions
- Post-COVID19 Condition
- Keywords
- Post-COVID-19 condition, long-COVID-19, vitamin D, cholecalciferol, interleukin-6, glutathione peroxidase, cough, dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Escuela Militar de Graduados de Sanidad, SEDENAUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 17 May 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.
The goal of this clinical trial is to evaluate the effectiveness of vitamin D supplementation in treating neuropsychiatric symptoms and improving antioxidant levels in individuals diagnosed with post-COVID-19 condition, a state known as long-COVID. These individuals are primarily adults who have recovered from severe COVID-19 and exhibit persistent symptoms. The main questions it aims to answer are:
Does vitamin D (cholecalciferol) supplementation decrease levels of anxiety and depression in patients with post-COVID-19 condition? Does vitamin D (cholecalciferol) supplementation increase glutathione peroxidase (GPx) activity in these patients? Researchers will compare the effects of daily versus bolus doses of vitamin D (cholecalciferol) to see if one method is more effective than the other in achieving sufficient vitamin D levels and improving clinical outcomes.
Participants will:
Be randomly assigned to receive either a daily dose or a bolus dose of vitamin D over an 8-week period.
Undergo blood tests to measure biochemical markers such as interleukin-6 (IL-6) and GPx before and two months after starting supplementation.
Have their lung function tested using spirometry and diffusing capacity for carbon monoxide.
Complete the Hospital Anxiety and Depression Scale to assess changes in anxiety and depression levels.
Detailed description
This clinical trial investigates the potential therapeutic benefits of vitamin D supplementation in individuals experiencing persistent health issues following recovery from severe COVID-19, commonly referred to as post-COVID-19 condition or long-COVID. The study primarily focuses on the neuropsychiatric symptoms such as anxiety and depression and the antioxidant enzyme activity, specifically glutathione peroxidase (GPx), which plays a critical role in mitigating oxidative stress within the body.
The trial is designed as a pilot, randomized controlled trial, where participants are divided into two groups to receive vitamin D in different dosing regimens: a daily dose and a bolus dose, administered weekly. This method allows for an examination of the efficacy of dosage frequency on achieving optimal serum vitamin D levels, which are hypothesized to influence the biochemical pathways involved in inflammatory and oxidative processes.
During the study, participants\' serum levels of 25-hydroxyvitamin D (25(OH)D), a marker for vitamin D status, are assessed to ensure they reach and maintain a target level that previous studies have associated with optimal immune function and reduced inflammation. The participants\' initial vitamin D status is carefully evaluated to tailor the supplementation dose according to individual needs, following a formula that considers their weight and the desired increase in 25(OH)D levels.
The antioxidant capacity of participants is measured through the activity of GPx in the blood. This enzyme is crucial for reducing oxidative stress, which is linked to various chronic diseases and has been suggested to play a significant role in the severity and progression of post-COVID-19 symptoms. By measuring GPx activity before and after vitamin D supplementation, the study aims to provide insights into the effectiveness of vitamin D in enhancing antioxidant defenses in post-COVID patients.
Furthermore, the trial includes an evaluation of lung function using high-resolution computed tomography (HRCT) and standard pulmonary function tests, including spirometry and the diffusing capacity of the lung for carbon monoxide (DLCO). These assessments help to determine any improvements in respiratory health, which is often compromised in patients with long-term COVID-19 effects.
The impact of vitamin D on neuropsychiatric symptoms is assessed using the Hospital Anxiety and Depression Scale (HADS), a validated tool that rates the severity of anxiety and depression symptoms. This aspect of the study highlights the potential of vitamin D not just as a physical health supplement but also as a modulator of mental health, particularly in the context of the ongoing recovery from a severe infectious disease.
By conducting this trial, the researchers aim to shed light on the broader implications of vitamin D supplementation, not only as a means of improving vitamin D status but also as a potentially significant intervention for improving the quality of life and health outcomes in individuals suffering from long-term effects of COVID-19.
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 achieve and maintain optimal serum vitamin D levels |
| Weekly Bolus Vitamin D Supplementation Group | Experimental | Drug: vitamin D (cholecalciferol) supplementationThis arm of the study involves administering a weekly bolus dose of vitamin D, equivalent to the total daily dose accumulated over the week, to investigate the efficacy of this regimen in improving vitamin D levels and reducing post-COVID-19 symptoms. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Post-COVID-19 Condition: Patients must have been previously diagnosed with COVID-19 and continue to experience persistent symptoms after recovery.
- Age: Participants must be adults aged 18 years or older.
- Vitamin D Deficiency: Initial serum 25-hydroxyvitamin D levels below 40 ng/mL.
- Completed Hospital Treatment for COVID-19: Patients must have been discharged from hospital treatment for COVID-19 at least 12 months prior to the study.
- Ability to Give Informed Consent: Participants must be capable of understanding and willing to sign a consent form.
Key exclusion criteria (6 listed)
- Reading and Writing Difficulties: Patients who have difficulties in reading and/or writing that would impede their understanding of the study requirements or communication with study staff.
- Inability to Perform Physical Tests: Patients unable to perform functional walk and spirometry tests.
- Untreated Chronic Non-Respiratory Diseases: Individuals suffering from untreated chronic diseases such as diabetes mellitus, systemic arterial hypertension, hypothyroidism, or epilepsy that could interfere with the study outcomes.
- Recent Use of Vitamin D Supplements: Patients who have taken vitamin D supplements within three months prior to the start of the study.
- Participation in Other Clinical Trials: Patients currently participating in other clinical trials that might conflict with this study's protocol.
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 clinical pilot study administered and compared daily and bolus dosing regi-mens of vitamin D to achieve and maintain optimal serum levels of 25(OH)D in post-COVID patients. The daily dose group received constant and gradual supplementation of cholecalciferol, intended to achieve more stable 25(OH)D levels without peaks. Conversely, the bolus group received a weekly dose that could lead to rapid increases followed by gradual declines 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 . | Drug | Daily Vitamin D Supplementation Group, Weekly Bolus Vitamin D Supplementation Group |
Primary outcome
Glutathione Peroxidase (GPx) Activity
Time frame: Baseline and two months post-supplementation
This measure assesses the antioxidant enzyme activity level in the blood, indicating the body's capacity to reduce oxidative stress. Increased activity of GPx is expected as a result of vitamin D supplementation
Serum Levels of Interleukin-6 (IL-6)
Time frame: Baseline and two months post-supplementation.
IL-6 is a pro-inflammatory cytokine. The study aims to observe changes in IL-6 levels, which might not be significantly altered by vitamin D supplementation as per preliminary findings.
2 secondary outcomes
Lung Function Tests
Time frame: Baseline and two months post-supplementation.
Neuropsychiatric Symptoms (Anxiety and Depression)
Time frame: Baseline and two months post-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 13 Jan 2025.
- Individual participant dataSharing planned: Yes. Upon completion of the study, and after publication of the primary findings, the following Individual Participant Data will be made available: Anonymized Participant Data: This includes all individual data collected during the trial, minus any personally identifiable information. Data types include: Demographic information (age, gender, etc.) Clinical data (symptoms, disease severity, etc.) Treatment data (dosage received, treatment duration, etc.) Outcome data (response to treatment, side effects, etc.) Laboratory results (vitamin D levels, IL-6 levels, GPx activity, etc.).
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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 Post-COVID19 Condition, 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 6 inclusion and 6 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 13 Jan 2025. 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 and two months post-supplementation). The study lists 2 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 13 Jan 2025.