Clinical trial NCT04733625: The Effect of Vitamin D Therapy on Morbidity and Moratlity in Patients With SARS-CoV 2 Infection
Official title: The Effect of Vitamin D Therapy on Morbidity and Moratlity in Patients With SARS-CoV 2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
SARS-CoV Infection
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Moreover, other exclusion criteria included those with known malignancy, with organ transplant, and those with known chronic autoimmune diseases and lastly those on systemic steroid for any cause

Primary outcomes:
measure: Death or need for intubation
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals
Study officials:
affiliation: Kasr Alainy faculty of medicine
name: Amin Roshdy, PHD
role: PRINCIPAL_INVESTIGATOR
References: