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

NCT04621058 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-07-15

No results posted yet for this study

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.

Conditions

  • SAR
  • SARS Pneumonia

Interventions

DRUG

Vitamin D

In case of Vitamin D levels \<30 or 40ng/ml patients will take vitamin D supplements.

DRUG

PLACEBO

Placebo capsules exactly the same as the above, but without the active component.

Sponsors & Collaborators

  • Fundación Eduardo Anitua

    collaborator OTHER

  • Bioaraba Health Research Institute

    lead NETWORK

Principal Investigators

  • Joaquín Durán Cantolla · Bioaraba Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04621058 on ClinicalTrials.gov