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Less than a week after JAMA network open published a small study showing that zinc and vitamin C were not associated with improvement in mild COVID-19 infections, a JAMA The 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 rheumatologist from Sao Paul, and colleagues, reported that the hospital stay was a median of 7.0 days for those in the intervention and the placebo group. , and while there were differences of up to 8.4 percentage points between in-hospital mortality, intensive care unit (ICU) admission, and mechanical ventilation requirements, they were all statistically not significant.
“In this clinical trial [in] isolation, the results may appear ambiguous; that is, the results do not exclude the clinically important benefits (or harms) of high-dose vitamin D3 administration in hospitalized patients with moderate to severe COVID-19, “US clinicians David Leaf, MD, MMSc, and Adit Ginde, MD, MPH, write in a JAMA comment.
“However, when combined with existing randomized clinical trials of administration of vitamin D in hospitalized patients with respiratory infection and severe disease, the results reported by Murai et al do not support routine administration of vitamin D in hospitalized patients with moderate to severe COVID-19. “
Safe but ineffective supplement
Researchers recruited adult patients in Sao Paulo who were hospitalized for COVID-19 but who did not require mechanical ventilation or intensive care admission at the time of enrollment. From June 2 to August 27, 2020, half of the 240 patients randomly received a single dose of 200,000 international units (IU) of 25-hydroxyvitamin D (25[OH]D) in addition to the standard of care, and the other half received a placebo. Three people were excluded from the final results because they withdrew their consent.
Patients were on average 56.2 years old and were randomized a median of 10.3 days after symptom onset 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% against 29.7%).
None of the primary or secondary results reached statistical significance. 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), ICU admission after enrollment was 16.0% vs. 21.2% (95% CI, -15.1% to 4.7%; P = 0.30) and 7.6% vs 14.4% required mechanical ventilation (95% CI, -15.1% to 1.2%; P = 0.09).
For patients requiring mechanical ventilation, there was no significant difference between duration (mean 15.0 days vs. 12.8; 95% CI, -8.4 to 12.8; P = 0.69).
Before the administration of the vitamin D doses, the patients’ 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 had severe deficiency (less than 12 ng / mL). While 25 (OH) D levels increased significantly to an average of 44.4 ng / mL in the vitamin D group, Leaf and Ginde point out that this does not measure how much the body was actually able to convert.
The only adverse reaction reported was vomiting.
Biggest RCT to date, but still undernourished
In the JAMA Comment, Leaf and Ginde say that although the results appear to show the insignificance of vitamin D for treatment with COVID-19 and that it is the largest randomized, double-blind, placebo-controlled trial evaluating the Vitamin published to date, the study had remarkable design limitations, including being undernourished.
“With 208 participants, they would have 80% power to detect a 50% difference in length of hospital stay, which is a highly unlikely outcome,” they write.
Additionally, they write, not only does the focus of the study on moderate to severe patients limit its generalization, but other anti-inflammatory COVID studies have had results highly dependent on the severity of the disease. The lack of vitamin D deficiency could also have impacted the results.
While this does not detract from the researchers’ final conclusions, they write: “Given the lack of highly effective therapies for COVID-19, with the possible exception of corticosteroids, it is important to remain open to emerging results. studies rigorously conducted on vitamins. D (despite smaller samples and significant limitations of some studies). “
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