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OpenTrials
Completed

NCT Number: NCT04733625

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

single injection of Vitamin D (200000 I.U

Other names: vitamin D

Placebo

Drug

placebo medication

Primary outcomes

  1. Death or need for intubation

    Time frame: 6 weeks

    In hospital death or need for intubation

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 2, 2021
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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