Post-COVID-19 SyndromeNCT05630339
Magnesium and Vitamin D Combination for Post-COVID Syndrome
A study testing Magnesium chloride and Vitamin D in people with Post-COVID-19 Syndrome and Long COVID, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-COVID-19 Syndrome, Long COVID, Vitamin D Deficiency
- What is being tested?
- Magnesium chloride and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jan 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects who have received magnesium and/or vitamin D supplements in the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Magnesium chloride, Vitamin D, Inert placebo
- Keywords
- Post-COVID syndrome, Long COVID, Vitamin D, Magnesium
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Vitamin D Deficiency, Magnesium Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium chlorideDietary supplement
Also called Magnesium
Each 650 mg capsule contains 340 mg of magnesium chloride, which must be ingested twice a day with aliments.
Vitamin DDietary supplement
Also called Cholecalciferol
Each tablet contains 4000 IU of vitamin D, and must be ingested a pill per night.
Inert placeboDietary supplement
Instead of dietary supplements, sodium bicarbonate as inert placebo will be administered twice a day in 650 mg capsules.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Magnesium chloride; Dietary Supplement: Vitamin D |
| Control group. | Placebo comparator | Will receive inert placebo for four months. Receives: Dietary Supplement: Inert placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First control date, and four months after treatment initiation.
Change from Baseline Post-COVID Functional Status at 4 months
Post-COVID Functional Status Scale
Measured: 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).
Measured: 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).
Measured: First control assessment, and four months after treatment initiation.
Change from Baseline Mental State levels at 4 months
Mini Mental State Examination
Measured: First control date, and four months after treatment initiation.
Change from Baseline Anxiety Symptoms at 4 months
Beck Anxiety Inventory
Measured: First control date, and four months after treatment initiation.
Change from Baseline Depression Symptoms at 4 months
Beck Depression Inventory
Measured: 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
Measured: First control date, and four months after treatment initiation.
Change from Baseline Dyspnea Symptoms at 4 months
modified Medical Research Council (mMRC) dyspnea scale
Measured: First control date, and four months after treatment initiation.
Secondary outcomes (4)
Change from Baseline Fasting Blood Glucose levels at 4 months
Normal values: 70 - 100 mg/dL
Measured: First control assessment, and four months after treatment initiation.
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.
Measured: First control assessment, and four months after treatment initiation.
Change from Baseline Serum Calcium levels at 4 months
Normal values: 8.4 - 10.2 mg/dL
Measured: First control assessment, and four months after treatment initiation.
Change from Baseline Serum Creatinine levels at 4 months
Normal values: 0.5 - 1.2 mg/dL
Measured: First control assessment, and four months after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start30 Jan 2022
- Primary completion1 May 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Consejo de Ciencia y Tecnología del Estado de Durango
- Responsible party
- Principal investigator, Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico
- Investigators
- Fernando Guerrero, PhD, Principal investigator, Instituto Mexicano del Seguro SocialGerardo Martínez, PhD, Study chair, Instituto Mexicano del Seguro SocialLuis Simental, PhD, Study chair, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630339
- Sponsor's protocol ID
- R-2021-785-076
- Status last verified
- Sep 2023
- First submitted
- 8 Nov 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.
PubMed 32437596Addison AB, Wong B, Ahmed T, Macchi A, Konstantinidis I, Huart C, Frasnelli J, Fjaeldstad AW, Ramakrishnan VR, Rombaux P, Whitcroft KL, Holbrook EH, Poletti SC, Hsieh JW, Landis BN, Boardman J, Welge-Lussen A, Maru D, Hummel T, Philpott CM. Clinical Olfactory Working Group consensus statement on the treatment of postinfectious olfactory dysfunction. J Allergy Clin Immunol. 2021 May;147(5):1704-1719. doi: 10.1016/j.jaci.2020.12.641. Epub 2021 Jan 13.
PubMed 33453291Ali N. Role of vitamin D in preventing of COVID-19 infection, progression and severity. J Infect Public Health. 2020 Oct;13(10):1373-1380. doi: 10.1016/j.jiph.2020.06.021. Epub 2020 Jun 20.
PubMed 32605780Amenta EM, Spallone A, Rodriguez-Barradas MC, El Sahly HM, Atmar RL, Kulkarni PA. Postacute COVID-19: An Overview and Approach to Classification. Open Forum Infect Dis. 2020 Oct 21;7(12):ofaa509. doi: 10.1093/ofid/ofaa509. eCollection 2020 Dec.
PubMed 33403218Aranow C. Vitamin D and the immune system. J Investig Med. 2011 Aug;59(6):881-6. doi: 10.2310/JIM.0b013e31821b8755.
PubMed 21527855Becker RC. COVID-19 and its sequelae: a platform for optimal patient care, discovery and training. J Thromb Thrombolysis. 2021 Apr;51(3):587-594. doi: 10.1007/s11239-021-02375-w. Epub 2021 Jan 27.
PubMed 33501596Behl T, Kaur I, Bungau S, Kumar A, Uddin MS, Kumar C, Pal G, Sahil, Shrivastava K, Zengin G, Arora S. The dual impact of ACE2 in COVID-19 and ironical actions in geriatrics and pediatrics with possible therapeutic solutions. Life Sci. 2020 Sep 15;257:118075. doi: 10.1016/j.lfs.2020.118075. Epub 2020 Jul 10.
PubMed 32653522Bellan M, Soddu D, Balbo PE, Baricich A, Zeppegno P, Avanzi GC, Baldon G, Bartolomei G, Battaglia M, Battistini S, Binda V, Borg M, Cantaluppi V, Castello LM, Clivati E, Cisari C, Costanzo M, Croce A, Cuneo D, De Benedittis C, De Vecchi S, Feggi A, Gai M, Gambaro E, Gattoni E, Gramaglia C, Grisafi L, Guerriero C, Hayden E, Jona A, Invernizzi M, Lorenzini L, Loreti L, Martelli M, Marzullo P, Matino E, Panero A, Parachini E, Patrucco F, Patti G, Pirovano A, Prosperini P, Quaglino R, Rigamonti C, Sainaghi PP, Vecchi C, Zecca E, Pirisi M. Respiratory and Psychophysical Sequelae Among Patients With COVID-19 Four Months After Hospital Discharge. JAMA Netw Open. 2021 Jan 4;4(1):e2036142. doi: 10.1001/jamanetworkopen.2020.36142.
PubMed 33502487Britton J, Pavord I, Richards K, Wisniewski A, Knox A, Lewis S, Tattersfield A, Weiss S. Dietary magnesium, lung function, wheezing, and airway hyperreactivity in a random adult population sample. Lancet. 1994 Aug 6;344(8919):357-62. doi: 10.1016/s0140-6736(94)91399-4.
PubMed 7914305Carvalho-Schneider C, Laurent E, Lemaignen A, Beaufils E, Bourbao-Tournois C, Laribi S, Flament T, Ferreira-Maldent N, Bruyere F, Stefic K, Gaudy-Graffin C, Grammatico-Guillon L, Bernard L. Follow-up of adults with noncritical COVID-19 two months after symptom onset. Clin Microbiol Infect. 2021 Feb;27(2):258-263. doi: 10.1016/j.cmi.2020.09.052. Epub 2020 Oct 5.
PubMed 33031948Dennis A, Wamil M, Alberts J, Oben J, Cuthbertson DJ, Wootton D, Crooks M, Gabbay M, Brady M, Hishmeh L, Attree E, Heightman M, Banerjee R, Banerjee A; COVERSCAN study investigators. Multiorgan impairment in low-risk individuals with post-COVID-19 syndrome: a prospective, community-based study. BMJ Open. 2021 Mar 30;11(3):e048391. doi: 10.1136/bmjopen-2020-048391.
PubMed 33785495Garg P, Arora U, Kumar A, Malhotra A, Kumar S, Garg S, Arora M, Sarda R, Wig N. Risk factors for prolonged fatigue after recovery from COVID-19. J Med Virol. 2021 Apr;93(4):1926-1928. doi: 10.1002/jmv.26774. Epub 2021 Jan 12. No abstract available.
PubMed 33393696Gasmi A, Tippairote T, Mujawdiya PK, Peana M, Menzel A, Dadar M, Gasmi Benahmed A, Bjorklund G. Micronutrients as immunomodulatory tools for COVID-19 management. Clin Immunol. 2020 Nov;220:108545. doi: 10.1016/j.clim.2020.108545. Epub 2020 Jul 22.
PubMed 32710937Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
PubMed 32291463Glasdam SM, Glasdam S, Peters GH. The Importance of Magnesium in the Human Body: A Systematic Literature Review. Adv Clin Chem. 2016;73:169-93. doi: 10.1016/bs.acc.2015.10.002. Epub 2016 Jan 13.
PubMed 26975973
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05630339
- Acronym / sponsor ID
- R-2021-785-076
- Keywords
- Post-COVID syndrome, Long COVID, Vitamin D, Magnesium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Consejo de Ciencia y Tecnología del Estado de Durango
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Magnesium chloride, Dietary Supplement: Vitamin DWill 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. | Placebo comparator | Dietary Supplement: Inert placeboWill receive inert placebo for four months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who have received magnesium and/or vitamin D supplements in the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium chlorideAlso: MagnesiumEach 650 mg capsule contains 340 mg of magnesium chloride, which must be ingested twice a day with aliments. | Dietary supplement | Intervention group |
| Vitamin DAlso: CholecalciferolEach tablet contains 4000 IU of vitamin D, and must be ingested a pill per night. | Dietary supplement | Intervention group |
| Inert placeboInstead of dietary supplements, sodium bicarbonate as inert placebo will be administered twice a day in 650 mg capsules. | Dietary supplement | Control group. |
Primary outcome
Change from Baseline Post-COVID syndrome symptoms at 4 months
Time frame: First control date, and four months after treatment initiation.
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
Time frame: First control date, and four months after treatment initiation.
Post-COVID Functional Status Scale
Change from Baseline Serum vitamin D levels at 4 months
Time frame: First control assessment, and four months after treatment initiation.
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
Time frame: First control assessment, and four months after treatment initiation.
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
Time frame: First control date, and four months after treatment initiation.
Mini Mental State Examination
Change from Baseline Anxiety Symptoms at 4 months
Time frame: First control date, and four months after treatment initiation.
Beck Anxiety Inventory
Change from Baseline Depression Symptoms at 4 months
Time frame: First control date, and four months after treatment initiation.
Beck Depression Inventory
Change from Baseline Post-traumatic Stress Symptoms at 4 months
Time frame: First control date, and four months after treatment initiation.
Severity of Post-traumatic Stress Symptoms
Change from Baseline Dyspnea Symptoms at 4 months
Time frame: First control date, and four months after treatment initiation.
modified Medical Research Council (mMRC) dyspnea scale
4 secondary outcomes
Change from Baseline Fasting Blood Glucose levels at 4 months
Time frame: First control assessment, and four months after treatment initiation.
Change from Baseline Serum Lipid Profile at 4 months
Time frame: First control assessment, and four months after treatment initiation.
Change from Baseline Serum Calcium levels at 4 months
Time frame: First control assessment, and four months after treatment initiation.
Change from Baseline Serum Creatinine levels at 4 months
Time frame: First control assessment, and four months after treatment initiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 32437596Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.
- Background: PubMed 33453291Addison AB, Wong B, Ahmed T, Macchi A, Konstantinidis I, Huart C, Frasnelli J, Fjaeldstad AW, Ramakrishnan VR, Rombaux P, Whitcroft KL, Holbrook EH, Poletti SC, Hsieh JW, Landis BN, Boardman J, Welge-Lussen A, Maru D, Hummel T, Philpott CM. Clinical Olfactory Working Group consensus statement on the treatment of postinfectious olfactory dysfunction. J Allergy Clin Immunol. 2021 May;147(5):1704-1719. doi: 10.1016/j.jaci.2020.12.641. Epub 2021 Jan 13.
- Background: PubMed 32605780Ali N. Role of vitamin D in preventing of COVID-19 infection, progression and severity. J Infect Public Health. 2020 Oct;13(10):1373-1380. doi: 10.1016/j.jiph.2020.06.021. Epub 2020 Jun 20.
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- 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 TeamLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Guerrero, PhD principal investigator
Instituto Mexicano del Seguro Social
Gerardo Martínez, PhD study chair
Instituto Mexicano del Seguro Social
Luis Simental, PhD study chair
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium chloride and Vitamin D in people with Post-COVID-19 Syndrome and Long COVID, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Post-COVID syndrome symptoms at 4 months (time frame: First control date, and four months after treatment initiation.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05630339, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.