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

NCT04621058 | Completed Phase 3 DMC

• 1 other identifier: VITD
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

SAR; SARS Pneumonia

Outcome Measures

Primary Outcomes (1)

• MORTALITY

  Mortality reduction

  At 21 days.

Secondary Outcomes (4)

• Intensive care admissions

  At 21 days

• Length of hospital stay

  AT 21 DAYS

• Prevalence of vitamin D deficiency

  At baseline

• Incremental cost effectiveness ratio (ICER)

  At 21 days

Study Arms (2)

D VITAMIN GROUP

EXPERIMENTAL

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

PLACEBO GROUP

PLACEBO COMPARATOR

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

Interventions

Vitamin D DRUG

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

Also known as: D VITAMIN GROUP

D VITAMIN GROUP

PLACEBO DRUG

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

Also known as: PLACEO GROUP

PLACEBO GROUP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bioaraba Health Research Institute: lead
• Fundación Eduardo Anitua: collaborator

Study Sites (1)

Joaquín Durán Cantolla

Vitoria-Gasteiz, Alava, 01002, Spain

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Joaquín Durán Cantolla

  Bioaraba Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind study, neither the patients, nor the researchers, nor those responsible for the statistical analysis will know the treatment that the patient is undergoing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 9, 2020
• Study Start: November 9, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

ES (1)