Zurita-Cruz Jessie, Fonseca-Tenorio Jeffry, Villasís-Keever Miguel, López-Alarcón Mardia, Parra-Ortega Israel, López-Martínez Briceida, Miranda-Novales Guadalupe
Faculty of Medicine, National Autonomous University of Mexico, Pediatric Hospital Federico Gómez, Mexico City, Mexico.
Infectious Diseases Department, Pediatric Hospital National Medical Center, XXI Century, Mexican Institute of Social Security, Mexico City, Mexico.
Front Pediatr. 2022 Jul 25;10:943529. doi: 10.3389/fped.2022.943529. eCollection 2022.
Some studies suggested that adequate levels of vitamin D (VD) decrease the risk of severe COVID-19. Information about the effectiveness of VD supplementation in children is scarce.
To assess the efficacy and safety of VD supplementation compared to the standard of care in hospitalized children with COVID-19.
An open-label randomized controlled single-blind clinical trial was carried out. We included patients from 1 month to 17 years, with moderate COVID-19, who required hospitalization and supplemental oxygen. They were randomized into two groups: the VD group, which received doses of 1,000 (children < 1 year) or 2,000 IU/day (from 1 to 17 years) and the group without VD (control). The outcome variables were the progression of oxygen requirement, the development of complications, and death.
For comparison between groups, we used the chi-squared test or Fisher's exact test and the Mann-Whitney test. Absolute risk reduction (ARR) and the number needed to treat (NNT) were calculated. ≤ 0.05 was considered statistically significant.
From 24 March 2020 to 31 March 2021, 87 patients were eligible to participate in the trial; 45 patients were randomized: 20 to the VD group and 25 to the control group. There was no difference in general characteristics at baseline, including serum VD levels (median 13.8 ng/ml in the VD group and 11.4 ng/ml in the control group).
2/20 (10%) in the VD group vs. 9/25 (36%) in the control group progressed to a superior ventilation modality ( = 0.10); one patient in the VD group died (5%) compared to 6 (24%) patients in the control group ( = 0.23). ARR was 26% (95% CI 8.8 to 60.2%) and NNT was 3 (2 to 11) for progression and ARR was 19% (95% CI -3.9 to 42.8%) and NNT was 6 (2 to 26) for death. None of the patients receiving VD had adverse effects. The trial was stopped for ethical reasons; since after receiving the results of the basal VD values, none of the patients had normal levels.
In this trial, VD supplementation in pediatric patients seems to decrease the risk of COVID-19 progression and death. More studies are needed to confirm these findings.
This protocol was registered on ClinicalTrials.gov with the registration number NCT04502667.
一些研究表明，充足的维生素D（VD）水平可降低患重症COVID-19的风险。关于补充VD对儿童有效性的信息很少。
评估与COVID-19住院儿童的标准治疗相比，补充VD的疗效和安全性。
开展了一项开放标签随机对照单盲临床试验。我们纳入了1个月至17岁、患有中度COVID-19、需要住院和补充氧气的患者。他们被随机分为两组：VD组，接受1000（<1岁儿童）或2000 IU/天（1至17岁）的剂量；无VD组（对照组）。结局变量为氧气需求进展、并发症发生情况和死亡情况。
为比较组间差异，我们使用了卡方检验或Fisher精确检验以及Mann-Whitney检验。计算了绝对风险降低率（ARR）和治疗所需人数（NNT）。P≤0.05被认为具有统计学意义。
从2020年3月24日至2021年3月31日，87例患者符合参与试验条件；45例患者被随机分组：20例进入VD组，25例进入对照组。基线时的一般特征无差异，包括血清VD水平（VD组中位数为13.8 ng/ml，对照组为11.4 ng/ml）。
VD组2/20（10%）进展为更高级别的通气方式，而对照组为9/25（36%）（P=0.10）；VD组1例患者死亡（5%），而对照组有6例（24%）患者死亡（P=0.23）。进展的ARR为26%（95%CI 8.8至60.2%），NNT为3（2至11）；死亡的ARR为19%（95%CI -3.9至42.8%），NNT为6（2至26）。接受VD的患者均未出现不良反应。该试验因伦理原因停止；因为在收到基础VD值结果后，没有患者的VD水平正常。
在本试验中，儿科患者补充VD似乎可降低COVID-19进展和死亡风险。需要更多研究来证实这些发现。
本方案已在ClinicalTrials.gov上注册，注册号为NCT04502667。
