Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419712
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-05-15
Brief Title:
Effect of Vitamin D Supplementation on Glutathione Peroxidase GPx Activity Interleukin-6 IL-6 Levels and Clinical Outcomes in Post-COVID-19 Patients
Sponsor:
Escuela Militar de Graduados de Sanidad SEDENA
Organization:
Escuela Militar de Graduados de Sanidad SEDENA
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITDPOSTCOVID
Brief 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 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
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 participants39 serum levels of 25-hydroxyvitamin D 25OHD 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 participants39 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 25OHD 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
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 participants39 serum levels of 25-hydroxyvitamin D 25OHD 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 participants39 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 25OHD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None