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Magnesium and Vitamin D Combination for Post-COVID Syndrome

Primary Purpose

Post-COVID-19 Syndrome, Long COVID, Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Magnesium chloride

Vitamin D

Inert placebo

About this trial

This is an interventional treatment trial for Post-COVID-19 Syndrome focused on measuring Post-COVID syndrome, Long COVID, Vitamin D, Magnesium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Men and women aged 18 or older. Previous diagnosis of COVID-19, confirmed by Real Time Polymerase Chain Reaction (RT-PCR) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Diagnosis of post-COVID syndrome Hypomagnesemia Vitamin D deficiency Exclusion Criteria: Subjects who have received magnesium and/or vitamin D supplements in the last 30 days

Sites / Locations

Biomedical Research Unit. IMSS. Durango

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group.

Arm Description

Will receive 1.2 g of magnesium chloride (equivalent to 360 mg of magnesium elemental) + 4000 IU of vitamin D once a day, for four months.

Will receive inert placebo for four months.

Outcomes

Primary Outcome Measures

Change from Baseline Post-COVID syndrome symptoms at 4 months

The presence of two or more of the following signs and/or symptoms will be considered a suspicion of post-COVID syndrome: Fatigue, shortness of breath, cough, joint pain, chest pain, muscle pain, headache, tachycardia, arrhythmias, loss of smell, loss of taste, memory problems, concentration problems, depression, anxiety, insomnia, skin rashes, hair loss.

Change from Baseline Post-COVID Functional Status at 4 months

Post-COVID Functional Status Scale

Change from Baseline Serum vitamin D levels at 4 months

Recovery of serum vitamin D levels from deficiency (< 30 ng/mL) to normally (30 - 100 ng/mL). The serum concentration of the 25 OH vitamin D fraction will be determined by the enzyme-linked immunosorbent assay (ELISA) method, the serum levels of magnesium and calcium by colorimetric techniques (A15 Clinical Analyzer, Biosystems, USA).

Change from Baseline Serum Magnesium levels at 4 months

Recovery of serum magnesium levels from deficiency (< 2.0 mg/dL) to normally (2.0 - 2.5 mg/dL).

Change from Baseline Mental State levels at 4 months

Mini Mental State Examination

Change from Baseline Anxiety Symptoms at 4 months

Beck Anxiety Inventory

Change from Baseline Depression Symptoms at 4 months

Beck Depression Inventory

Change from Baseline Post-traumatic Stress Symptoms at 4 months

Severity of Post-traumatic Stress Symptoms

Change from Baseline Dyspnea Symptoms at 4 months

modified Medical Research Council (mMRC) dyspnea scale

Secondary Outcome Measures

Change from Baseline Fasting Blood Glucose levels at 4 months

Normal values: 70 - 100 mg/dL

Change from Baseline Serum Lipid Profile at 4 months

Normal values: total cholesterol 100 - 200 mg/dL; HDL-cholesterol 40 - 60 mg/dL; triglycerides 50 - 150 mg/dL.

Change from Baseline Serum Calcium levels at 4 months

Normal values: 8.4 - 10.2 mg/dL

Change from Baseline Serum Creatinine levels at 4 months

Normal values: 0.5 - 1.2 mg/dL

Full Information

NCT ID

NCT05630339

First Posted

November 8, 2022

Last Updated

September 27, 2023

Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

Consejo de Ciencia y Tecnología del Estado de Durango

1. Study Identification

Unique Protocol Identification Number

NCT05630339

Brief Title

Magnesium and Vitamin D Combination for Post-COVID Syndrome

Official Title

Efficacy and Security of the Magnesium and Vitamin D Combination as Adjuvant Treatment of Post-COVID Syndrome. A Randomised Double-blind Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

January 30, 2022 (Actual)

Primary Completion Date

May 1, 2023 (Actual)

Study Completion Date

September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

Consejo de Ciencia y Tecnología del Estado de Durango

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 goal of this double-blind randomized controlled clinical trial is to determine the efficacy of the administration of magnesium chloride + vitamin D as an adjuvant in the treatment of post-Coronavirus Disease (COVID) syndrome. The participants will be integrated: a) Intervention group that will receive 1 g of magnesium chloride (equivalent to 300 mg of elemental magnesium) + 4000 IU of vitamin D once a day, for four months. b) Control group that will receive inert placebo for four months. The outcome variable will be the improvement of the post-COVID syndrome. At the beginning and end of the study, blood samples will be taken to determine serum levels of vitamin D, total magnesium, ionic magnesium, calcium, fasting glucose and lipid profile. The evaluation of the efficacy and safety of the proposed intervention will be carried out by establishing the differences between the intervention and control groups.

Detailed Description

More than 50 signs and symptoms have been described that characterize the post-COVID syndrome, among them the early presence of fatigue, shortness of breath, cough, joint and chest pain. Later, the signs and symptoms that may occur are muscle pain, headache, tachycardia, loss of smell or taste, memory and concentration problems, difficulty falling asleep, skin rashes and hair loss. Vitamin D is a fat-soluble vitamin whose best-known function is calcium and phosphate homeostasis, but it is also involved in multiple processes, including the regulation of the immune response. In vitro, vitamin D decreases viral replication, which is linked to its ability to stimulate innate immunity, increases the synthesis of cathelicidin and defensins, peptides that favor the preservation of the mucosa and enhance its protective effect against infection. In vivo, vitamin D decreases the expression of the cellular co-receptor dipeptidyl peptidase (DPP)-4/cluster of differentiation antigen 26 (CD26), which interacts with protein S, which decreases the penetration of the virus into the cell, contributes to the regulation of immunity, regulating excessive immune response, which is associated with an adverse prognosis, and interacts with the nuclear factor-kappa B (NF-kB) pathway, decreases the intensity of the Th1 response and the synthesis of proinflammatory cytokines, and increases the synthesis of anti-inflammatory cytokines. Magnesium, through its calcium channel blocking effect, decreases the inflammatory response produced by the NF-kB cascade, reduces the production of tumor necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) by monocytes and the expression of cytokines and inflammatory proteins. It influences both cell-mediated and humoral adaptive immunity, since it participates in the activation of leukocytes, the binding of antigens to macrophages, apoptotic regulation, and it reduces the production of superoxide anions. The pathophysiology of the post-COVID syndrome is not precisely known, although it has been established that it is a disorder with inflammatory components, endothelial damage, and thromboembolism. In this context, magnesium deficiency is associated with the development of the pro-inflammatory and pro-thrombotic response that generates a favorable microenvironment for the development of inflammation, endothelial damage and thromboembolism, components linked to the post-COVID syndrome. On the other hand, it has been described that patients with post-COVID present with vitamin D deficiency, a deficiency that contributes to the development of fatigue, anemia and chronic inflammation. In addition, there is interaction between magnesium and vitamin D, in such a way that the deficiency of the first contributes to the decrease in the synthesis of 25-hydroxy vitamin D and 1,25-hydroxy vitamin D and the number and activity of vitamin D receptors. Therefore, it is plausible to assume that both magnesium and vitamin D play an important role in the development of post-COVID syndrome. Goal. To determine the efficacy of the administration of magnesium chloride + vitamin D as an adjuvant in the treatment of post-COVID syndrome. Methods. Double-blind randomized controlled clinical trial to which subjects diagnosed with post-COVID syndrome will be integrated. The participants will be integrated: a) Intervention group that will receive 1 g of magnesium chloride (equivalent to 300 mg of elemental magnesium) + 4000 IU of vitamin D once a day, for four months. b) Control group that will receive inert placebo for four months. Men and women, aged 18 years or older, with a diagnosis of post-COVID syndrome, hypomagnesaemia and vitamin D insufficiency will be included. Having received magnesium or vitamin D supplements in the last 30 days, as well as treatment based on of steroids, will be exclusion criteria. The withdrawal of informed consent and adherence to the intervention less than 80% will be criteria for elimination. The outcome variable will be the improvement of the post-COVID syndrome. At the beginning and end of the study, blood samples will be taken to determine serum levels of vitamin D, total magnesium, ionic magnesium, calcium, fasting glucose and lipid profile. Statistic analysis. The evaluation of the efficacy and safety of the proposed intervention will be carried out by establishing the differences between the intervention and control groups, which will be estimated using the unpaired Student's t-test for analysis of the parametric variables (Mann-Whitney U for non-parametric variables) and Chi-Square (Fisher's exact test) for the analysis of categorical variables. Intragroup differences will be estimated using the paired Student's t-test. Even when it is assumed that the confounding variables will be controlled by the randomization process; Additionally, a stratified analysis will be carried out by those confounding variables that in the bivariate analysis show significant differences.

6. Conditions and Keywords

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

Post-COVID-19 Syndrome, Long COVID, Vitamin D Deficiency, Magnesium Deficiency

Keywords

Post-COVID syndrome, Long COVID, Vitamin D, Magnesium

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Study groups: Intervention group that will receive 1.2 g of magnesium chloride (equivalent to 360 mg of magnesium elemental) + 4000 IU of vitamin D once a day, for four months. Control group that will receive inert placebo for four months.

Masking

ParticipantCare Provider

Masking Description

Neither the patient nor the treating doctor will know the study group the participant was randomized.

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Will receive 1.2 g of magnesium chloride (equivalent to 360 mg of magnesium elemental) + 4000 IU of vitamin D once a day, for four months.

Arm Title

Control group.

Arm Type

Placebo Comparator

Arm Description

Will receive inert placebo for four months.

Intervention Type

Dietary Supplement

Intervention Name(s)

Magnesium chloride

Other Intervention Name(s)

Magnesium

Intervention Description

Each 650 mg capsule contains 340 mg of magnesium chloride, which must be ingested twice a day with aliments.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

Cholecalciferol

Intervention Description

Each tablet contains 4000 IU of vitamin D, and must be ingested a pill per night.

Intervention Type

Dietary Supplement

Intervention Name(s)

Inert placebo

Intervention Description

Instead of dietary supplements, sodium bicarbonate as inert placebo will be administered twice a day in 650 mg capsules.

Primary Outcome Measure Information:

Title

Change from Baseline Post-COVID syndrome symptoms at 4 months

Description

Time Frame

First control date, and four months after treatment initiation.

Title

Change from Baseline Post-COVID Functional Status at 4 months

Description

Post-COVID Functional Status Scale

Time Frame

First control date, and four months after treatment initiation.

Title

Change from Baseline Serum vitamin D levels at 4 months

Description

Time Frame

First control assessment, and four months after treatment initiation.

Title

Change from Baseline Serum Magnesium levels at 4 months

Description

Recovery of serum magnesium levels from deficiency (< 2.0 mg/dL) to normally (2.0 - 2.5 mg/dL).

Time Frame

First control assessment, and four months after treatment initiation.

Title

Change from Baseline Mental State levels at 4 months

Description

Mini Mental State Examination

Time Frame

First control date, and four months after treatment initiation.

Title

Change from Baseline Anxiety Symptoms at 4 months

Description

Beck Anxiety Inventory

Time Frame

First control date, and four months after treatment initiation.

Title

Change from Baseline Depression Symptoms at 4 months

Description

Beck Depression Inventory

Time Frame

First control date, and four months after treatment initiation.

Title

Change from Baseline Post-traumatic Stress Symptoms at 4 months

Description

Severity of Post-traumatic Stress Symptoms

Time Frame

First control date, and four months after treatment initiation.

Title

Change from Baseline Dyspnea Symptoms at 4 months

Description

modified Medical Research Council (mMRC) dyspnea scale

Time Frame

First control date, and four months after treatment initiation.

Secondary Outcome Measure Information:

Title

Change from Baseline Fasting Blood Glucose levels at 4 months

Description

Normal values: 70 - 100 mg/dL

Time Frame

First control assessment, and four months after treatment initiation.

Title

Change from Baseline Serum Lipid Profile at 4 months

Description

Normal values: total cholesterol 100 - 200 mg/dL; HDL-cholesterol 40 - 60 mg/dL; triglycerides 50 - 150 mg/dL.

Time Frame

First control assessment, and four months after treatment initiation.

Title

Change from Baseline Serum Calcium levels at 4 months

Description

Normal values: 8.4 - 10.2 mg/dL

Time Frame

First control assessment, and four months after treatment initiation.

Title

Change from Baseline Serum Creatinine levels at 4 months

Description

Normal values: 0.5 - 1.2 mg/dL

Time Frame

First control assessment, and four months after treatment initiation.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Guerrero, PhD

Organizational Affiliation

Instituto Mexicano del Seguro Social

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gerardo Martínez, PhD

Organizational Affiliation

Instituto Mexicano del Seguro Social

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Luis Simental, PhD

Organizational Affiliation

Instituto Mexicano del Seguro Social

Official's Role

Study Chair

Facility Information:

Facility Name

Biomedical Research Unit. IMSS. Durango

City

Durango

State/Province

Dgo

ZIP/Postal Code

34067

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-conditions.html

Description

Centers for Disease Control and Prevention

URL

http://patientresearchcovid19.com/research/report-1/

Description

Patient-Led Research Collaborative. Report: What Does COVID-19 Recovery Actually Look Like? An Analysis of the Prolonged COVID-19 Symptoms Survey by Patient-Led Research Team

Learn more about this trial

Magnesium and Vitamin D Combination for Post-COVID Syndrome

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