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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
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
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
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).
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
Accepts Healthy Volunteers
Eligibility Criteria
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
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
No
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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

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Magnesium and Vitamin D Combination for Post-COVID Syndrome

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