Back to results

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

Primary Purpose

Covid19, SARS-CoV Infection

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Cholecalciferol

Placebo

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cairo university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention(Vitamin D therapy

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Death or need for intubation

In hospital death or need for intubation

Secondary Outcome Measures

Full Information

NCT ID

NCT04733625

First Posted

January 31, 2021

Last Updated

January 31, 2021

Sponsor

Kasr El Aini Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04733625

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

September 15, 2020 (Actual)

Primary Completion Date

December 17, 2020 (Actual)

Study Completion Date

December 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, SARS-CoV Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention(Vitamin D therapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

vitamin D

Intervention Description

single injection of Vitamin D (200000 I.U

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo medication

Primary Outcome Measure Information:

Title

Death or need for intubation

Description

In hospital death or need for intubation

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amin Roshdy, PHD

Organizational Affiliation

Kasr Alainy faculty of medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo university hospitals

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs