Studies find that vitamin D has no effect on moderate to severe COVID

Within 1 week JAMA network open Published a small study showing that zinc and vitamin C are not associated with amelioration of mild COVID-19 infection, 240 people JAMA The study also found that a single dose of vitamin D had no significant effect on moderate to severe COVID-19 infections.

In this study, published yesterday by Saint Paul’s rheumatologists Igor Murai, PhD and colleagues, hospitalization was median 7.0 days in both the intervention and placebo groups, with in-hospital mortality and intensive care room (ICU). ) Admission and the need for rheumatism were all not statistically significant.

“When this clinical trial is conducted [in] When separated, the results may appear ambiguous. That is, the findings do not rule out clinically significant benefits (or harms) from high doses of vitamin D.₃ Administration of moderate to severe COVID-19 to inpatients, “said US clinicians David Leaf, MD, MMSc, ​​and Adit Ginde, MD, MPH. JAMA Commentary.

“But the results reported by Murai et al., Combined with existing randomized clinical trials of vitamin D administration in inpatients with respiratory infections and serious illness, show that inpatients with moderate to severe COVID-19. Does not support daily administration of vitamin D in. “”

Safe but ineffective supplement

Researchers recruited adult patients who were hospitalized in São Paulo for COVID-19 but did not require ventilator or ICU admission at the time of enrollment. From June 2nd to August 27th, 2020, half of the 240 patients were randomly assigned a single dose of 200,000 international units (IU) of 25-hydroxyvitamin D (25).[OH]D) In ​​addition to standard treatment, the other half was assigned a placebo. The three withdrew their consent and were excluded from the final result.

The mean age of the patients was 56.2 years, with a randomized median of 10.3 days after onset and 1.4 days after admission. The most common comorbidities were obesity (57.8% in the intervention group vs. 53.7% in the placebo group), hypertension (56.3% vs. 49.2%), and diabetes (41.2% vs. 29.7%).

Neither the primary nor secondary results 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), ICU admission after registration is 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 respiration, there was no significant difference between the periods (15.0 mean days vs 12.8; 95% CI, -8.4 to 12.8; P = 0.69).

Patients’ average vitamin D levels prior to vitamin D were 21.2 nanograms / 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). 25 (OH) D levels increased significantly to an average of 44.4 ng / mL in the vitamin D group, but Leaf and Ginde point out that this does not measure the amount that the body could actually convert.

The only adverse effect reported was one case of vomiting.

It’s the biggest RCT ever, but it’s still underpowered

In JAMA Commentary, Leaf and Ginde, the results appear to indicate the importance of vitamin D to the treatment of COVID-19 and are the largest randomized, double-blind, placebo-controlled trial to evaluate vitamins ever published. However, he states that the study had notable design limitations. Including lack of power.

“With 208 participants, the ability to detect a 50% difference in length of stay is 80%, which is a very unlikely result,” they write.

In addition, they write that not only did studies focused on moderate to severe patients limit their generalization, but other COVID anti-inflammatory studies resulted in highly dependent on the severity of the disease. .. Lack of vitamin D deficiency may also have affected the outcome.

This does not undermine the researcher’s final conclusion, but he writes: D (despite the small sample size and significant limitations in some studies). “