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 range18 Years – 70 Years

SexALL

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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…

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