The Effect of Vitamin D Therapy on Morbidity and Moratlity in Patients With SARS-CoV 2 Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Death or need for intubation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Cholecalciferol (Drug)
Placebo
16 diabetic patients with vitamin D deficiancy and COVID-19 POSITIVE
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Death or need for intubation
Time Frame: 6 weeks
In hospital death or need for intubation
Secondary Outcomes
No secondary outcomes reported
Investigators
Tarek Samy Abdelaziz
Associate professor
Kasr El Aini Hospital