CompletedNot Applicable

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

Mexico54 participantsStarted 2022-11-25

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 curre…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glutathione Peroxidase (GPx) Activity

Timeframe: Baseline and two months post-supplementation

Serum Levels of Interleukin-6 (IL-6)

Timeframe: Baseline and two months post-supplementation.

Trial details

NCT IDNCT06419712

SponsorEscuela Militar de Graduados de Sanidad, SEDENA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-20

View on ClinicalTrials.gov More Post-COVID19 Condition trials