Last reviewed · How we verify
NCT06585995: VDCOVID19ACUTE
Effectiveness and Safety of Two Vitamin D3 Supplementation Regimens in Adults with Early-stage COVID-19
NA trial testing vitamin D (cholecalciferol) supplementation in COVID-19 in 216 participants. Completed in 10 May 2024.
28 March 2024
Quick facts
| Lead sponsor | Escuela Militar de Graduados de Sanidad, SEDENA |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 216 |
| Start date | 29 April 2022 |
| Primary completion | 28 March 2024 |
| Estimated completion | 10 May 2024 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- vitamin D (cholecalciferol) supplementation — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Escuela Militar de Graduados de Sanidad, SEDENA — full company profile →
Who can join
Adults 18 to 60, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aimed to determine the effectiveness and safety of individualized vitamin D3 supplementation in adult patients with early-stage severe COVID-19. The goal was to see if vitamin D3 could reduce the risk of progressing to critical COVID-19, characterized by severe respiratory distress and other life-threatening complications. The research question was: What is the effect of vitamin D3 on serum calcidiol levels during the active phase of the disease in adult patients with COVID-19? The study hypothesized that an accelerated vitamin D3 supplementation regimen in adult patients with COVID-19 would achieve the ideal serum calcidiol level (40-60 ng/ml) during the active phase of the disease. This was a randomized controlled clinical trial with two parallel groups. The first group, the accelerated supplementation group, received a single monthly dose of vitamin D3, while the second group, the daily supplementation group, received a daily dose of vitamin D3 during their hospital stay. A total of 216 patients were included in the study and were randomly assigned to one of the two groups. Key procedures and measurements included the collection of three blood samples from each patient during their hospital stay-at admission (day 1), on day 7, and on day 14. Biomarker analysis measured serum levels of vitamin D3, Von Willebrand Factor, interleukin-6 (IL-6), and glutathione peroxidase. Clinical monitoring was conducted to track the development of critical COVID-19, the need for mechanical ventilation, and overall clinical outcomes, such as recovery or death. The importance of this study lay in the role of vitamin D3 in immune regulation, as it had been identified as a protective factor against severe respiratory infections. By determining the optimal supplementation strategy, this study hoped to improve clinical outcomes for COVID-19 patients, reduce mortality rates, and prevent the progression to critical illness. Inclusion criteria for the study were adult patients aged 18-65 years with early-stage severe COVID-19, who had signed informed consent and had no contraindications for vitamin D3 supplementation. Exclusion criteria included patients with other severe comorbidities, those who were pregnant, those requiring immediate intensive care, and patients with a history of conditions that affect vitamin D metabolism. Safety and efficacy monitoring tracked the vitamin D3 levels and correlated them with inflammation markers, oxidative stress, and thrombotic status to evaluate the impact of supplementation. Clinical progression was also monitored to assess the safety and efficacy of the vitamin D3 regimens. Outcome measures included changes in serum calcidiol levels, correlation of calcidiol levels with biomarkers (IL-6, glutathione peroxidase, Von Willebrand Factor), duration and intensity of COVID-19 symptoms, incidence of critical COVID-19, need for mechanical ventilation, and overall clinical outcomes (recovery or death). This study aimed to provide valuable insights into the role of vitamin D3 in managing severe COVID-19, potentially informing treatment guidelines and improving patient outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06585995
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of vitamin D (cholecalciferol) supplementation
Trials testing the same drug.
- NCT07078708 — Effectiveness of Non-hormonal Treatment on Moderate to Severe Premenstrual Syndrome · NA · completed
- NCT06419712 — Effect of Vitamin D Supplementation on Glutathione Peroxidase (GPx) Activity, Interleukin-6 (IL-6) Levels and Clinical O · NA · completed
Other recruiting trials for COVID-19
Currently open trials in the same condition.
- NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Escuela Militar de Graduados de Sanidad, SEDENA trials
Trials by the same sponsor.
- NCT06419712 — Effect of Vitamin D Supplementation on Glutathione Peroxidase (GPx) Activity, Interleukin-6 (IL-6) Levels and Clinical O · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06585995 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Escuela Militar de Graduados de Sanidad, SEDENA
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06585995.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing