Less than a week later JAMA Network open published a small study showing that zinc and vitamin C are not associated with improved mild COVID-19 infections, a 240-person JAMA study also found that a single dose of vitamin D had no significant effect on moderate to severe COVID-19 infections.
The study, published yesterday by Igor Murai, PhD, a Sao Paul rheumatologist, and colleagues, reported that the hospital stay was a median of 7.0 days for those in the intervention and the placebo group, and although there are differences was up to 8.4 percentage points in hospital, mortality rate, intensive care unit (ICU) and mechanical ventilation needs, it was not all statistically significant.
“When this clinical trial is being conducted [in] isolation, the findings may appear ambiguous; that is, the findings do not exclude clinically significant benefits (or harms) from high dose vitamin D3 administration to hospitalized patients with moderate to severe COVID-19, “write US clinicians David Leaf, MD, MMSc and Adit Ginde, MD, MPH, in a related JAMA commentary.
“Together with existing randomized clinical trials of vitamin D administration in hospitalized patients with respiratory infection and critical illness, the results reported by Murai et al. Do not support the routine administration of vitamin D in hospitalized patients with moderate to severe COVID-19. not. “
Supplement safe but ineffective
The researchers recruited adult patients in Sao Paulo who were admitted to the hospital with COVID-19, but who did not require mechanical ventilation or ICU admission during enrollment. From 2 June to 27 August 2020, half of the 240 patients randomly received a single dose of 200,000 International Units (IU) 25-hydroxyvitamin D (25[OH]D) in addition to the standard of care, and the other half was awarded a placebo. Three people were excluded from the final results because they withdrew their consent.
Patients were on average 56.2 years old and they were randomized to a median of 10.3 days after onset of the symptom and a median of 1.4 days after hospitalization. The most common comorbidities were obesity (57.8% of the intervention group versus 53.7% of the placebo group), high blood pressure (56.3% versus 49.2%) and diabetes (41.2% versus 29.7%) .
None of the primary or secondary outcomes achieved statistical significance. In hospital, mortality was 7.6% in the treatment group and 5.1% in the placebo group (95% confidence interval [CI]-4.1% to 9.2%; P = 0.43), the admission to ICU after enrollment was 16.0% versus 21.2% (95% GI, -15.1% to 4.7%; P = 0.30), and 7.6% versus 14.4% require mechanical ventilation (95% BI, -15.1% to 1.2%; P = 0.09).
For patients requiring mechanical ventilation, there was no significant difference in duration (15.0 mean days versus 12.8; 95% BI, -8.4 to 12.8; P = 0.69).
Before doses of vitamin D were administered, the patient’s average vitamin D level was 21.2 nanograms per milliliter (ng / ml) in the intervention group and 20.6 ng / ml in the placebo group – 20 ng / ml is considered healthy. And only about a quarter of all participants have a severe deficiency (less than 12 ng / ml). While 25 (OH) D levels rose significantly to an average of 44.4 ng / ml in the vitamin D group, Leaf and Ginde point out that it does not measure how much the body was able to convert.
The only side effect reported was one case of vomiting.
Largest RCT to date, but still submissive
In the JAMA comments, Leaf and Ginde say that although the results appear to be insignificant for vitamin D for COVID-19 treatment and are the largest randomized, double-blind, placebo-controlled study evaluating the vitamin published to date, the study had significant design limits. including being submissive.
“With 208 participants, they will have 80% power to detect a 50% difference in hospital length, which is an extremely unlikely result,” they write.
In addition, they not only limit the generalization of the study to moderate to severe patients, but other COVID anti-inflammatory studies have had results that are highly dependent on the severity of the disease. The lack of vitamin D deficiency could also affect the results.
Although this does not detract from the final conclusions of the researchers, they write: “Given the lack of highly effective therapies against COVID-19, except perhaps for corticosteroids, it is important to remain open to emerging results from carefully conducted studies on vitamins. D (despite smaller sample sizes and important limitations of some studies). “