A Phase 3 interventional study of Vitamin D and PLACEBO in SAR and SARS Pneumonia, sponsored by Bioaraba Health Research Institute. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Bioaraba Health Research Institute · Phase 3, Interventional, and Treatment
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.
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%.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 108 is close to the median of 106 across 1,247 interventional studies indexed under Pneumonia.
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Exclusion Criteria:
The administration of vitamin D will be carried out using the following treatment scheme: If vitamin D deficiency (\< 30 ng/ml) treatment with 2 capsules of 0.266 mg If vitamin D deficiency (\< 40 ng/ml): treatment with 1 capsule of 0.266 mg Blood levels of vitamin D will be determined on day 1, 4, 7 and 14. Based on the results from day 14, a new determination is recommended 4 weeks after starting treatment with the primary care physician who will decide whether to continue or interrupt the treatment. This phase will be carried out outside of the study. In addition, the product should only be administered, if blood calcium and phosphorus levels are within normal limits, as well as if the creatinuria/calciuria ratio is within normal ranges.
Drug: Vitamin D
The procedure will be the same as in the experimental group but instead of the active component, patients will take placebo capsules exactly the same as above but without the active component.
Drug: PLACEBO
In case of Vitamin D levels \<30 or 40ng/ml patients will take vitamin D supplements.
Also known as: D VITAMIN GROUP
Placebo capsules exactly the same as the above, but without the active component.
Also known as: PLACEO GROUP
MORTALITY
Mortality reduction
Time frame: At 21 days.
Intensive care admissions
Intensive care admissions reduction
Time frame: At 21 days
Length of hospital stay
Length of hospital stay reduction
Time frame: AT 21 DAYS
Prevalence of vitamin D deficiency
To assess the prevalence of vitamin D deficiency at baseline
Time frame: At baseline
Incremental cost effectiveness ratio (ICER)
To calculate the incremental cost per event (mortality) avoided
Time frame: At 21 days
Plan to share: Undecided
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Bioaraba Health Research Institute