Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04621058 |
| Other study ID # |
VITD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 9, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Bioaraba Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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%.
