Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT04621058
Brief Summary:
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.
OBJECTIVES:
PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.
SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.
METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
Detailed Description:
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.
OBJECTIVES:
PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.
SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.
METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
Inclusion criteria: Adult patients admitted to the Respiratory/Internal Medicine Unit of Santiago hospital of the OSI Araba HUA for acute pneumonia and suffering from a vitamin D deficit (\< 30 ng/ml) and a RT-PCR, in nasopharyngeal exudate, positive for SARS-CoV-2.
Exclusion criteria: 1)Patients taking any type of vitamin D supplement. 2)Patients with hypoparathyroidism. 3) Patients in whom the administration of vitamin D is formally contraindicated. 4) Patients who cannot take vitamin D orally.
OUR SIZE: In order to answer to the main objective (mortality reduction 21% versus 50% intervention and control group respectively), we will need a total sample of 108 evaluable subjects-54 patients per group (J Crit Care. 2018;44:300-5).Statistical power 90%,95% statistical significance with possible loss of follow-up of 5% of patients.
A recruitment period of about 12 months is needed.
STATISTICAL ANALYSIS: In order to answer to the main and secondary objectives (mortality and ICU admission), the Chi-square test will be performed and in the event that any of the frequencies is less than 5, the exact Fisher test will be used.
Depending on the distribution of the quantitative variables, the Student t-test for independent samples or the non-parametric Mann-Whitney U-test will be used, respectively.
The analysis criterion will be "by intention to treat". In all cases. The statistical significance will be 95%.
Study:
NCT04621058
Study Brief:
Protocol Section:
NCT04621058