Efficacy of Vitamin D Treatment in Mortality Reduction Due to COVID-19.

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioaraba Health Research Institute
• Collaborator: Fundación Eduardo Anitua
• Treatments: Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Admitted to the Respiratory or Internal medicine Units of Santiago hospital (HUA) due to pneumonia.

• Vitamin D deficiency (25(OH) defined by blood levels below 30 mg/ml.

• Possibility for observation during the treatment period.

• Signing of written consent (oral informed consent exceptionally).

• Positive PCR for diagnosis of sars-cov2 infection

Exclusion Criteria:

• Patients taking any type of vitamin D supplement.

• Patients with hypoparathyroidism.

• Pregnant or lactating women.

• Patients in whom the administration of vitamin D is formally contraindicated (see annex VI).

• Patients who at time of inclusion, cannot take vitamin D orally.