Effect of Vitamin D Supplementation on Glutathione Peroxidase (GPx) Activity, Interleukin-6 (IL-6) Levels and Clinical Outcomes in Post-COVID-19 Patients

NCT06419712 | Completed DMC

• 1 other identifier: C32-22
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID19 Condition

Keywords

Post-COVID-19 condition; long-COVID-19; vitamin D; cholecalciferol; interleukin-6; glutathione peroxidase; cough; dyspnea; fatigue; anxiety; depression

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline and two months post-supplementation.

Secondary Outcomes (2)

• Lung Function Tests

  Baseline and two months post-supplementation.

• Neuropsychiatric Symptoms (Anxiety and Depression)

  Baseline and two months post-supplementation.

Other Outcomes (2)

• Symptoms of Cough, Dyspnea, and Fatigue

  Baseline and two months post-supplementation.

• Serum 25-Hydroxyvitamin D Levels

  Baseline and two months post-supplementation.

Study Arms (2)

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

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.

Drug: vitamin D (cholecalciferol) supplementation

Interventions

vitamin D (cholecalciferol) supplementation DRUG

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 .

Daily Vitamin D Supplementation Group; Weekly Bolus Vitamin D Supplementation Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escuela Militar de Graduados de Sanidad, SEDENA: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Cough; Dyspnea; Fatigue; Anxiety Disorders; Depression

Interventions

Vitamin D; Cholecalciferol; Dietary Supplements

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR. IVÁN IGNACIO MEJÍA

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 17, 2024
• Study Start: November 25, 2022
• Primary Completion: April 20, 2023
• Study Completion: May 25, 2023
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)