The Effect of Vitamin D Therapy on Morbidity and Moratlity in Patients With SARS-CoV 2 Infection

NCT ID: NCT04733625

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2020-12-17

Brief Summary

The ongoing pandemic of SARS CoV-2 virus is calling for effective preventive and theraputic interventions. Vitamin D has been shown to play immunemodulatory functions in human. Low vitamin D levels have been linked to increased susciptability to infections especially the acute respiratory infections. This randomised controlled study aims to explore the effect of vitamin D administration on the outcome of SARS- CoV2 virus

Detailed Description

Background: Coronavirus disease COVID-19 is an ongoing pandemic and is causing avoidable fatalities worldwide. Vitamin D plays an essential role in the immune system. Vitamin D interferes with the majority of the immune systems cells such as macrophages, B and T lymphocytes, neutrophils and dendritic cells. We aim to find whether supplementation of vitamin D deficient diabetes with a single intramuscular cholecalciferol injection could improve the prognosis of those patients.

Patients and Methods: This was a placebo controlled randomized prospective study, included cohorts of 40 diabetes elderly patients who got infected with SARS-CoV-2 compared with 16 elderly diabetes patients matched of the same age group who got infected with SARS-CoV-2 but given a placebo instead intramuscularly were used as a control. Clinical, laboratory, treatment, and outcome data were recorded after six weeks of follow up especially ICU admissions and fate of COVID-19 disease.Vitamin D was given as a single intramuscular injection during period of the study.

Conditions

Covid19; SARS-CoV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention(Vitamin D therapy

40 patients with diabetes and vitamin D deficinecy that are Covid-19 positive. a single dose of Cholecaciferol will be administered

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

single injection of Vitamin D (200000 I.U

Placebo

16 diabetic patients with vitamin D deficiancy and COVID-19 POSITIVE

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo medication

Interventions

Cholecalciferol

single injection of Vitamin D (200000 I.U

Intervention Type: DRUG

Placebo

placebo medication

Intervention Type: DRUG

Other Intervention Names

vitamin D

Eligibility Criteria

Inclusion Criteria

• Elderly type II diabetes adult with age more than 60 years males and females having deficient serum vitamin D levels (less than 25 ng/ml).

Diabetes patients recruited to the control group were only included in the study if not known to have cholecalciferol supplementation within last 6 weeks. All elderly vitamin D deficient diabetes patients were diagnosed with COVID-19 when throat-swab specimens for SARS-CoV-2 PCR were positive.

Exclusion Criteria

• patients with known history of renal stones, diagnosis of hypercalcemia with the past year, baseline serum total calcium more than 10mg/dl, established diagnosis associated with increase the risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism), and current vitamin D supplementation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tarek Samy Abdelaziz

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amin Roshdy, PHD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy faculty of medicine

Locations

Cairo university hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

KA-2020/151

Identifier Type: -

Identifier Source: org_study_id