Efficacy of vitamin D treatment in patients diagnosed with pneumonia who require hospital admission and have vitamin D deficiency and a positive diagnosis for SARS-Cov-2 (COVID-19)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001960-28-ES

Enrollment

108

Registered

2020-05-26

Start date

2020-05-25

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 infection

Interventions

Trade Name: Hidroferol 0,266 mg cápsulas blandas Pharmaceutical Form: Capsule, soft Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Older patients of both sexes - Admitted to the Respiratory and / or Internal Medicine Unit of the Hospital De Santiago, the OSI Araba HUA is walking due to pneumonia - Possibility for observation during the treatment period - Signature of written and, exceptionally oral, informed consent - Have requested the test for SARS-CoV-2 (nasopharyngeal exudate PCR) and obtain positive results - Having a deficiency of vitamin D (25 (OH) vitamin D), defined by blood levels below 30 mg / ml Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 48

Exclusion criteria

Exclusion criteria: - Patients taking any type of vitamin D supplement - Patients with hypoparathyroidism - Pregnant or lactating women - Patients in whom vitamin D administration is formally contraindicated - Patients who cannot take vitamin D orally at the time of enrollment

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess whether the group of patients receiving vitamin D supplements presents a less serious evolution of his pneumonia translated into lower mortality than patients who do not receive this supplement;Secondary Objective: - Determine the number of ICU admissions in both groups - To determine the hospital stay (days of admission) in both study groups - Estimate the prevalence of vitamin D deficiency in all the patients studied and the efficacy of the supplementation strategy in correcting hypervitaminosis D with a record of episodes of hypercalcemia or hypelcalciuria - Request at baseline (study), 24 and 48 hours after placebo supplementation or vitamin D and at the end of the protocol, the permit for storage in the Basque Research Biobank of plasma, serum and urine samples (at -80ºC) that allows the hypotheses of interest to be evaluated a posteriori - Establish the final degree of complexity of both groups according to the international classification - Carrying out a cost-effectiveness study on the value of vitamin D treatment in these patients;Primary end point(s): Thus evaluating patients receiving vitamin D substitutes present a less serious evolution of respiratory syndrome compared to patients who do not receive a supplement, in terms of mortality and ICU admission;Timepoint(s) of evaluation of this end point: Until the end of the study	—

Measure

Time frame

Main Objective: Assess whether the group of patients receiving vitamin D supplements presents a less serious evolution of his pneumonia translated into lower mortality than patients who do not receive this supplement;Secondary Objective: - Determine the number of ICU admissions in both groups - To determine the hospital stay (days of admission) in both study groups - Estimate the prevalence of vitamin D deficiency in all the patients studied and the efficacy of the supplementation strategy in correcting hypervitaminosis D with a record of episodes of hypercalcemia or hypelcalciuria - Request at baseline (study), 24 and 48 hours after placebo supplementation or vitamin D and at the end of the protocol, the permit for storage in the Basque Research Biobank of plasma, serum and urine samples (at -80ºC) that allows the hypotheses of interest to be evaluated a posteriori - Establish the final degree of complexity of both groups according to the international classification - Carrying out a cost-effectiveness study on the value of vitamin D treatment in these patients;Primary end point(s): Thus evaluating patients receiving vitamin D substitutes present a less serious evolution of respiratory syndrome compared to patients who do not receive a supplement, in terms of mortality and ICU admission;Timepoint(s) of evaluation of this end point: Until the end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): - Diagnosis (SARS-CoV-2 positive / negative) - Disease severity determined based on the categories established according to the clinic presented by the patients included in the study - Blood vitamin D concentration - Clinical symptoms - Days in ICU / hospital - Discharge date - Drug use (specify drugs and doses) - Death (Yes / No) - Income costs;Timepoint(s) of evaluation of this end point: Until the end of the study	—

Measure

Time frame

Secondary end point(s): - Diagnosis (SARS-CoV-2 positive / negative) - Disease severity determined based on the categories established according to the clinic presented by the patients included in the study - Blood vitamin D concentration - Clinical symptoms - Days in ICU / hospital - Discharge date - Drug use (specify drugs and doses) - Death (Yes / No) - Income costs;Timepoint(s) of evaluation of this end point: Until the end of the study

—

Countries

Spain

Contacts

Public ContactInés Pérez Francisco

Investigation Institute Bioaraba

INES.PEREZFRANCISCO@osakidetza.eus

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026