Effect of Vitamin D on Morbidity and Mortality of the COVID-19 (COVID-VIT-D)

Fundación para la Investigación Biosanitaria del Principado de Asturias

Status and phase: Unknown; Phase 4

Conditions: COVID-19

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT04552951

2020-019-PF-CAANJ

Details and patient eligibility

About

Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19).

Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.

Full description

Efficacy parameters to compare both groups (vitamin D and No vitamin D).

Time to reach undetectable levels of SARS COV2 Infection.

Time of normalization of symptoms and clinical parameters.

Time of normalization of radiological images.

Time of normalization of biochemical markers.

Time of normalization of molecular inflammatory markers.

Transfer to the Intensive care Unit.

Mortality rate.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 year
• Diagnosis of COVID-19
• Accept to participate in the study ( consent)

Exclusion criteria

• Pregnancy
• Allergy to vitamin D
• Consumption of any form of vitamin D during the last 3 months
• Expected fatal outcome in the next 24 hours
• Cognitive deterioration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Active

Active Comparator group

Description:

Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed

Treatment:

Drug: Cholecalciferol

Control

No Intervention group

Description:

No vitamin D