Magnesium and Vitamin D Combination for Post-COVID Syndrome

NCT05630339 | Completed

• 1 other identifier: R-2021-785-076
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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.

  First control date, and four months after treatment initiation.

• Change from Baseline Post-COVID Functional Status at 4 months

  Post-COVID Functional Status Scale

  First control date, and four months after treatment initiation.

• 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).

  First control assessment, and four months after treatment initiation.

• 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).

  First control assessment, and four months after treatment initiation.

• Change from Baseline Mental State levels at 4 months

  Mini Mental State Examination

  First control date, and four months after treatment initiation.

• Change from Baseline Anxiety Symptoms at 4 months

  Beck Anxiety Inventory

  First control date, and four months after treatment initiation.

• Change from Baseline Depression Symptoms at 4 months

  Beck Depression Inventory

  First control date, and four months after treatment initiation.

• Change from Baseline Post-traumatic Stress Symptoms at 4 months

  Severity of Post-traumatic Stress Symptoms

  First control date, and four months after treatment initiation.

• Change from Baseline Dyspnea Symptoms at 4 months

  modified Medical Research Council (mMRC) dyspnea scale

  First control date, and four months after treatment initiation.

Secondary Outcomes (4)

• Change from Baseline Fasting Blood Glucose levels at 4 months

  First control assessment, and four months after treatment initiation.

• Change from Baseline Serum Lipid Profile at 4 months

  First control assessment, and four months after treatment initiation.

• Change from Baseline Serum Calcium levels at 4 months

  First control assessment, and four months after treatment initiation.

• Change from Baseline Serum Creatinine levels at 4 months

  First control assessment, and four months after treatment initiation.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Dietary Supplement: Magnesium chloride; Dietary Supplement: Vitamin D

Control group.

PLACEBO COMPARATOR

Will receive inert placebo for four months.

Dietary Supplement: Inert placebo

Interventions

Magnesium chloride DIETARY_SUPPLEMENT

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

Also known as: Magnesium

Intervention group

Vitamin D DIETARY_SUPPLEMENT

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

Also known as: Cholecalciferol

Intervention group

Inert placebo DIETARY_SUPPLEMENT

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

Control group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects who have received magnesium and/or vitamin D supplements in the last 30 days

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Consejo de Ciencia y Tecnología del Estado de Durango: collaborator

Study Sites (1)

Biomedical Research Unit. IMSS. Durango

Durango, Durango, 34067, Mexico

Location

Related Publications (52)

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Related Links

• 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

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Vitamin D Deficiency; Magnesium Deficiency

Interventions

Magnesium Chloride; Magnesium; Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Magnesium Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Fernando Guerrero, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Gerardo Martínez, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Luis Simental, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the patient nor the treating doctor will know the study group the participant was randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the research unit

Model Details: Study groups: 1. 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. 2. Control group that will receive inert placebo for four months.

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 29, 2022
• Study Start: January 30, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)