Covid19NCT04810949
Vitamine D3 Supplementation in Patients With Serum Values +/- 20ng/ml
A study testing Vitamine D3 supplementation and Diet and sun exposure in people with Covid19 and Influenza A, run by Hospital Clinica Nova at 1 site in Mexico.
Trial summary
Scarce information exists in relation to the effect of supplementation of Vitamin D3 in SARS-COV-2 infection, H1N1, and A, B Influenza when 25-hydroxyvitamin levels are between 20-100ng/ml. This study will evaluate the effect of supplementation of vitamin D3 vs. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Influenza A, Influenza B
- What is being tested?
- Vitamine D3 supplementation and Diet and sun exposure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteMexico
- Study dates
- 5 Aug 2020to 1 Mar 2021
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-90 years
- Both genders
- Absence of infection by COVID-19, influenza H1N1, influenza A or B at the time of measurement of serum vitamin D levels.
- Absence of infection at any site of bacterial, fungal or other origins
- Health worker at Hospital Clínica Nova.
- Patient Exclusion Criteria for both arms:
Show all 9Show fewer
- Serum Vitamin D levels> 100ng / ml
- Previous consumption of supplements containing Vitamin D3
- Pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Clinica Nova de Monterrey
San Nicolás de los Garza, Nuevo León, 66450
About this study
Official title: Effect of Vitamin D Supplementation on the Development of Respiratory Infections (COVID-19) in Health Personnel at Hospital Clínica NOVA With Serum Values> 20ng / ml
Scarce information exists in relation to the effect of supplementation of Vitamin D3 in SARS-COV-2 infection, H1N1, and A, B Influenza when 25-hydroxyvitamin levels are between 20-100ng/ml. This study will evaluate the effect of supplementation of vitamin D3 vs. dietary-hygiene measures in SARS-COV-2 , H1N1, A, B Influenza infection rate in patients with serum 25-hydroxyvitamin D3 levels >20ng/ml.
A comparative randomized study that will evaluate the effect of a monthly supplementation with 52000 units of Vitamine D3 during three months vs hygienic-dietary measures in the development of respiratory infections such as COVID-19, H1N1, A, B Influenza during 6 months of follow-up in health workers from a hospital in Northern Mexico with serum vitamin D values +/- 20ng/ml. Also, patients that during screening have 25-hydroxyvitamin D3 levels <20 ng/ml will receive vitamin D supplementation according to primary care discretion for three months and will be followed for 6 months and infection rate will be analyzed and compared.
Read the detailed description
COVID-19 is an infectious disease caused by the newly discovered coronavirus SARS-CoV-2, with a clinical spectrum from asymptomatic infection to critical and fatal illnesses. Influenza H1N1, A, and B have also been the most frequent etiologies of respiratory tract infection that are usually affected during the winter season before COVID-19 pandemic.
There is controversy against Vitamin D3 supplementation in the prevention of respiratory tract infections. A previous meta-analysis has demonstrated an association between vitamin D3 levels <20mg/dl and a higher risk of infection. There is less information in relation to the effect of supplementation when vitamin levels are between 20-100ng/ml and the prevention of infection.
The rationale of this study will be to find a relationship between vitamin D3 supplementation and the incidence of SARS-CoV-2 or Influenza H1N1, A, or B infection through a prospective study. Vitamin D3 could have a role in innate and adaptive immunity that could help prevent this disease. The target population will be health workers with a high risk of SARS-COV-2 or influenza infection with vitamin D > 20 ng/ml.
The primary aim is to evaluate the effect of vitamin D3 supplementation vs. dietary-hygiene measures in developing SARS-COV-2 infection, Influenza H1N1, A or B in patients with serum 25-hydroxyvitamin D3 >20 ng/ml.
A secondary aim will be to compare a group of hospital workers with serum 25-hydroxyvitamin D3 < 20 ng/ml that could or not have been supplemented with Vitamin D3.
Hypothesis primary aim: There will be no difference in the development of respiratory infections (COVID-19, H1N1 Influenza, A, B influenza) in health personnel with serum levels of vitamin D equal or greater than 20ng / ml when they receive supplementation vs treatment based on hygienic-dietary measures (diet and sun exposure), in a 6-month follow-up.
The hypothesis of secondary aim: the infection rate of COVID-19, and H1N1, A or B influenza will be higher in the group of vitamin D3 <20ng/ml than the patients with levels between 20-100ng/ml
A comparative quasi-experimental study that will evaluate the effect of 2 treatments in health workers of Hospital Clínica Nova with serum vitamin D values > 20ng / ml. The study will be conducted per The Code of Ethics of the World Medical Association (Declaration of Helsinki) for humans experiments and also will be approved by the local IRB from Universidad de Monterrey.
- Supplementation with 52,000 units of vitamin D3 monthly
- Hygienic-dietary measures: sun exposure 10 minutes a day plus recommendation of consumption of foods rich in vitamin D.
Baseline serum levels will be assessed, and monthly follow-up will be given regarding the development of symptoms suggestive of respiratory tract infection. The monitoring of serum levels of vitamin D will be every 3 months.
Efficacy endpoint: During the follow-up period, the most effective treatment will develop a lower respiratory tract infection rate ( COVID-19 and/or H1N1, A or B Influenza ).
Procedures:
- Serum levels of vitamin D (25-hydroxyvitamin D) will be measured in all medical personnel working at Hospital Clínica Nova.
- Patients with Vitamin D3<20ng/ml will be supplemented by primary care physician
- Treatment group will be randomized to patients with vitamin D3 levels >20ngml.
- Serum vitamin D levels will be monitored every 3 months
- Monthly follow-up will be given through the endocrinology consultation on the development of respiratory symptoms
Secondary endpoint: Personnel with vitamin D levels <20ng/ml will be sent to a primary care physician for treatment by the doctor's discretion and will be followed for the same period of time in order to evaluate COVID-19 and H1N1, A or B Influenza infection rate.
The relative risks that could be presented in the different groups are an increase of Vitamin D serum levels > 100ng /ml in the G1 and a reduction of vitamin D serum levels < 20ng/ml in G2. To reduce the risk, serum vitamin D3 levels will be monitored every three months.
Statistical analysis Two researchers will review the quality control of the database and anonymized it. Normality assumption will be evaluated with the Shapiro Wilk test and frequency histograms. Descriptive statistics such as mean, the standard deviation for quantitative variables, frequencies, and percentages for categorical variables, will be computed. Chi-square tests and ANOVA will be used to compare the categorical and quantitative data between groups. Kaplan-Mayer, Log-rank, and Cox regression were used for the analysis of SARS-COV-2 development.
Missing data were handled by complete case analysis. For simple randomization, we will use a random number generation with binomial distribution with a probability of 50%.
The sample size will be of a finite population as it will include all health personnel who work at Hospital Clínica Nova.
- Conditions
- Covid19, Influenza A, Influenza B, H1N1 Influenza
- Being tested
- Vitamine D3 supplementation, Diet and sun exposure
- Medical subject headings
- COVID-19, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamine D3 supplementationDietary supplement
- The supplementation treatment will consist of prescribing vitamin D3 consumption of 4000 U 13 single dose tablets each month (52,000 IU).
Diet and sun exposureDietary supplement
- Hygienic-dietary recommendations will consist of 2 steps
- Sun exposure at least 10 minutes a day from 10: 00-6: 00 pm
- Consumption of foods rich in vitamin D: milk, fish, almonds, mushrooms
| Study group | Role | What they receive |
|---|---|---|
| serum vitamin D levels >20ng/ml (Group 1) | Experimental | Patients with serum vitamin D levels >20ng/ml that will receive Vitamin D supplementation Receives: Dietary Supplement: Vitamine D3 supplementation |
| serum vitamin D levels >20ng/ml ( Group 2) | Experimental | Patients with vitamin D levels >20ng/ml that will receive diet and hygiene measures Receives: Dietary Supplement: Diet and sun exposure |
| serum vitamin D3 levels < 20ng/ml (Group3) | Other | Patients with Vitamin D levels<20ng/ml will receive vitamin D3 supplementation according to primary care discresion Receives: Dietary Supplement: Vitamine D3 supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Covid-19 Infection with Vitamin D3 > 20ng/ml
Evaluate the number of patients that get infected by COVID-19 during study period with vitamin D3 levels >20ng/ml that receive supplementation or diet and hygiene measures
Measured: 6 months
Number of participants with Influenza H1N1 infection with Vitamin D3 > 20ng/ml
Evaluate the number of patients that get infected by H1N1 infection with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
Measured: 6 months
Number of participants with Influenza A infection with Vitamin D3 > 20ng/ml
Evaluate the number of patients that get infected by Influenza A with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
Measured: 6 months
Number of participants with Influenza B infection with Vitamin D3 > 20ng/ml
Evaluate the number of patietns that get infected by Influenza B with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
Measured: 6 months
Secondary outcomes (4)
Number of participants with Covid-19 Infection with Vitamin D3 < 20ng/ml
Evaluate the number of patients that get infected by COVID-19 during study period with vitamin D3 levels <20ng/ml that receive supplementation according to primary care physician
Measured: 6 months
Number of participants with H1N1 infection Infection with Vitamin D3 < 20ng/ml
Evaluate the number of patients that get infected by H1N1 during study period with vitamin D3 levels <20ng/ml that receive supplementation according to primary care physician prescription
Measured: 6 months
Number of participants with influenza A Infection with Vitamin D3 < 20ng/ml
Evaluate the number of patients that get infected by Influenza A during study period with vitamin D3 levels <20ng/ml that receive supplementation according to primary care physician prescription
Measured: 6 months
Number of participants with influenza B Infection with Vitamin D3 < 20ng/ml
Evaluate the number of patients that get infected by Influenza B during study period with vitamin D3 levels <20ng/ml that receive supplementation according to primary care physician prescription
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start5 Aug 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Why it stopped: patients enrolled got vaccinated vs COVID-19 and Influenza
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinica Nova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Elena Romero Ibarguengoitia, Hospital Clinica Nova
- Investigators
- Arnulfo Gonzalez-Cantu, MD, Principal investigator, Hospital Clinica Nova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810949
- Sponsor's protocol ID
- Vitamina D NOVA
- Status last verified
- Apr 2022
- First submitted
- 18 Mar 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Spiteri G, Fielding J, Diercke M, Campese C, Enouf V, Gaymard A, Bella A, Sognamiglio P, Sierra Moros MJ, Riutort AN, Demina YV, Mahieu R, Broas M, Bengner M, Buda S, Schilling J, Filleul L, Lepoutre A, Saura C, Mailles A, Levy-Bruhl D, Coignard B, Bernard-Stoecklin S, Behillil S, van der Werf S, Valette M, Lina B, Riccardo F, Nicastri E, Casas I, Larrauri A, Salom Castell M, Pozo F, Maksyutov RA, Martin C, Van Ranst M, Bossuyt N, Siira L, Sane J, Tegmark-Wisell K, Palmerus M, Broberg EK, Beaute J, Jorgensen P, Bundle N, Pereyaslov D, Adlhoch C, Pukkila J, Pebody R, Olsen S, Ciancio BC. First cases of coronavirus disease 2019 (COVID-19) in the WHO European Region, 24 January to 21 February 2020. Euro Surveill. 2020 Mar;25(9):2000178. doi: 10.2807/1560-7917.ES.2020.25.9.2000178.
PubMed 32156327Griffin G, Hewison M, Hopkin J, Kenny RA, Quinton R, Rhodes J, Subramanian S, Thickett D. Perspective: Vitamin D supplementation prevents rickets and acute respiratory infections when given as daily maintenance but not as intermittent bolus: implications for COVID-19. Clin Med (Lond). 2021 Mar;21(2):e144-e149. doi: 10.7861/clinmed.2021-0035. Epub 2021 Feb 16.
PubMed 33593830Dzopalic T, Bozic-Nedeljkovic B, Jurisic V. The role of vitamin A and vitamin D in modulation of the immune response with a focus on innate lymphoid cells. Cent Eur J Immunol. 2021;46(2):264-269. doi: 10.5114/ceji.2021.103540. Epub 2021 Aug 7.
PubMed 34764797Bilezikian JP, Bikle D, Hewison M, Lazaretti-Castro M, Formenti AM, Gupta A, Madhavan MV, Nair N, Babalyan V, Hutchings N, Napoli N, Accili D, Binkley N, Landry DW, Giustina A. MECHANISMS IN ENDOCRINOLOGY: Vitamin D and COVID-19. Eur J Endocrinol. 2020 Nov;183(5):R133-R147. doi: 10.1530/EJE-20-0665.
PubMed 32755992Ilie PC, Stefanescu S, Smith L. The role of vitamin D in the prevention of coronavirus disease 2019 infection and mortality. Aging Clin Exp Res. 2020 Jul;32(7):1195-1198. doi: 10.1007/s40520-020-01570-8. Epub 2020 May 6.
PubMed 32377965Oristrell J, Oliva JC, Casado E, Subirana I, Dominguez D, Toloba A, Balado A, Grau M. Vitamin D supplementation and COVID-19 risk: a population-based, cohort study. J Endocrinol Invest. 2022 Jan;45(1):167-179. doi: 10.1007/s40618-021-01639-9. Epub 2021 Jul 17.
PubMed 34273098Dror AA, Morozov N, Daoud A, Namir Y, Yakir O, Shachar Y, Lifshitz M, Segal E, Fisher L, Mizrachi M, Eisenbach N, Rayan D, Gruber M, Bashkin A, Kaykov E, Barhoum M, Edelstein M, Sela E. Pre-infection 25-hydroxyvitamin D3 levels and association with severity of COVID-19 illness. PLoS One. 2022 Feb 3;17(2):e0263069. doi: 10.1371/journal.pone.0263069. eCollection 2022.
PubMed 35113901Demir M, Demir F, Aygun H. Vitamin D deficiency is associated with COVID-19 positivity and severity of the disease. J Med Virol. 2021 May;93(5):2992-2999. doi: 10.1002/jmv.26832. Epub 2021 Feb 9.
PubMed 33512007Chiodini I, Gatti D, Soranna D, Merlotti D, Mingiano C, Fassio A, Adami G, Falchetti A, Eller-Vainicher C, Rossini M, Persani L, Zambon A, Gennari L. Vitamin D Status and SARS-CoV-2 Infection and COVID-19 Clinical Outcomes. Front Public Health. 2021 Dec 22;9:736665. doi: 10.3389/fpubh.2021.736665. eCollection 2021.
PubMed 35004568Loucera C, Pena-Chilet M, Esteban-Medina M, Munoyerro-Muniz D, Villegas R, Lopez-Miranda J, Rodriguez-Bano J, Tunez I, Bouillon R, Dopazo J, Quesada Gomez JM. Real world evidence of calcifediol or vitamin D prescription and mortality rate of COVID-19 in a retrospective cohort of hospitalized Andalusian patients. Sci Rep. 2021 Dec 3;11(1):23380. doi: 10.1038/s41598-021-02701-5.
PubMed 34862422Quesada-Gomez JM, Entrenas-Castillo M, Bouillon R. Vitamin D receptor stimulation to reduce acute respiratory distress syndrome (ARDS) in patients with coronavirus SARS-CoV-2 infections: Revised Ms SBMB 2020_166. J Steroid Biochem Mol Biol. 2020 Sep;202:105719. doi: 10.1016/j.jsbmb.2020.105719. Epub 2020 Jun 11.
PubMed 32535032Martinez-Moreno JM, Herencia C, Montes de Oca A, Munoz-Castaneda JR, Rodriguez-Ortiz ME, Diaz-Tocados JM, Peralbo-Santaella E, Camargo A, Canalejo A, Rodriguez M, Velasco-Gimena F, Almaden Y. Vitamin D modulates tissue factor and protease-activated receptor 2 expression in vascular smooth muscle cells. FASEB J. 2016 Mar;30(3):1367-76. doi: 10.1096/fj.15-272872. Epub 2015 Dec 23.
PubMed 26700731Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
PubMed 21646368
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on the Development of Respiratory Infections (COVID-19) in Health Personnel at Hospital Clínica NOVA With Serum Values> 20ng / ml
- ClinicalTrials.gov ID
- NCT04810949
- Acronym / sponsor ID
- Vitamina D NOVA
- Conditions
- Covid19, Influenza A, Influenza B, H1N1 Influenza
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patients enrolled got vaccinated vs COVID-19 and Influenza
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hospital Clinica NovaUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 23 Mar 2021 (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.
Scarce information exists in relation to the effect of supplementation of Vitamin D3 in SARS-COV-2 infection, H1N1, and A, B Influenza when 25-hydroxyvitamin levels are between 20-100ng/ml. This study will evaluate the effect of supplementation of vitamin D3 vs. dietary-hygiene measures in SARS-COV-2 , H1N1, A, B Influenza infection rate in patients with serum 25-hydroxyvitamin D3 levels >20ng/ml.
A comparative randomized study that will evaluate the effect of a monthly supplementation with 52000 units of Vitamine D3 during three months vs hygienic-dietary measures in the development of respiratory infections such as COVID-19, H1N1, A, B Influenza during 6 months of follow-up in health workers from a hospital in Northern Mexico with serum vitamin D values +/- 20ng/ml. Also, patients that during screening have 25-hydroxyvitamin D3 levels <20 ng/ml will receive vitamin D supplementation according to primary care discretion for three months and will be followed for 6 months and infection rate will be analyzed and compared.
Detailed description
COVID-19 is an infectious disease caused by the newly discovered coronavirus SARS-CoV-2, with a clinical spectrum from asymptomatic infection to critical and fatal illnesses. Influenza H1N1, A, and B have also been the most frequent etiologies of respiratory tract infection that are usually affected during the winter season before COVID-19 pandemic.
There is controversy against Vitamin D3 supplementation in the prevention of respiratory tract infections. A previous meta-analysis has demonstrated an association between vitamin D3 levels <20mg/dl and a higher risk of infection. There is less information in relation to the effect of supplementation when vitamin levels are between 20-100ng/ml and the prevention of infection.
The rationale of this study will be to find a relationship between vitamin D3 supplementation and the incidence of SARS-CoV-2 or Influenza H1N1, A, or B infection through a prospective study. Vitamin D3 could have a role in innate and adaptive immunity that could help prevent this disease. The target population will be health workers with a high risk of SARS-COV-2 or influenza infection with vitamin D > 20 ng/ml.
The primary aim is to evaluate the effect of vitamin D3 supplementation vs. dietary-hygiene measures in developing SARS-COV-2 infection, Influenza H1N1, A or B in patients with serum 25-hydroxyvitamin D3 >20 ng/ml.
A secondary aim will be to compare a group of hospital workers with serum 25-hydroxyvitamin D3 < 20 ng/ml that could or not have been supplemented with Vitamin D3.
Hypothesis primary aim: There will be no difference in the development of respiratory infections (COVID-19, H1N1 Influenza, A, B influenza) in health personnel with serum levels of vitamin D equal or greater than 20ng / ml when they receive supplementation vs treatment based on hygienic-dietary measures (diet and sun exposure), in a 6-month follow-up.
The hypothesis of secondary aim: the infection rate of COVID-19, and H1N1, A or B influenza will be higher in the group of vitamin D3 <20ng/ml than the patients with levels between 20-100ng/ml
A comparative quasi-experimental study that will evaluate the effect of 2 treatments in health workers of Hospital Clínica Nova with serum vitamin D values > 20ng / ml. The study will be conducted per The Code of Ethics of the World Medical Association (Declaration of Helsinki) for humans experiments and also will be approved by the local IRB from Universidad de Monterrey.
- Supplementation with 52,000 units of vitamin D3 monthly
- Hygienic-dietary measures: sun exposure 10 minutes a day plus recommendation of consumption of foods rich in vitamin D.
Baseline serum levels will be assessed, and monthly follow-up will be given regarding the development of symptoms suggestive of respiratory tract infection. The monitoring of serum levels of vitamin D will be every 3 months.
Efficacy endpoint: During the follow-up period, the most effective treatment will develop a lower respiratory tract infection rate ( COVID-19 and/or H1N1, A or B Influenza ).
Procedures:
- Serum levels of vitamin D (25-hydroxyvitamin D) will be measured in all medical personnel working at Hospital Clínica Nova.
- Patients with Vitamin D3<20ng/ml will be supplemented by primary care physician
- Treatment group will be randomized to patients with vitamin D3 levels >20ngml.
- Serum vitamin D levels will be monitored every 3 months
- Monthly follow-up will be given through the endocrinology consultation on the development of respiratory symptoms
Secondary endpoint: Personnel with vitamin D levels <20ng/ml will be sent to a primary care physician for treatment by the doctor's discretion and will be followed for the same period of time in order to evaluate COVID-19 and H1N1, A or B Influenza infection rate.
The relative risks that could be presented in the different groups are an increase of Vitamin D serum levels > 100ng /ml in the G1 and a reduction of vitamin D serum levels < 20ng/ml in G2. To reduce the risk, serum vitamin D3 levels will be monitored every three months.
Statistical analysis Two researchers will review the quality control of the database and anonymized it. Normality assumption will be evaluated with the Shapiro Wilk test and frequency histograms. Descriptive statistics such as mean, the standard deviation for quantitative variables, frequencies, and percentages for categorical variables, will be computed. Chi-square tests and ANOVA will be used to compare the categorical and quantitative data between groups. Kaplan-Mayer, Log-rank, and Cox regression were used for the analysis of SARS-COV-2 development.
Missing data were handled by complete case analysis. For simple randomization, we will use a random number generation with binomial distribution with a probability of 50%.
The sample size will be of a finite population as it will include all health personnel who work at Hospital Clínica Nova.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| serum vitamin D levels >20ng/ml (Group 1) | Experimental | Dietary Supplement: Vitamine D3 supplementationPatients with serum vitamin D levels >20ng/ml that will receive Vitamin D supplementation |
| serum vitamin D levels >20ng/ml ( Group 2) | Experimental | Dietary Supplement: Diet and sun exposurePatients with vitamin D levels >20ng/ml that will receive diet and hygiene measures |
| serum vitamin D3 levels < 20ng/ml (Group3) | Other | Dietary Supplement: Vitamine D3 supplementationPatients with Vitamin D levels<20ng/ml will receive vitamin D3 supplementation according to primary care discresion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-90 years
- Both genders
- Absence of infection by COVID-19, influenza H1N1, influenza A or B at the time of measurement of serum vitamin D levels.
- Absence of infection at any site of bacterial, fungal or other origins
- Health worker at Hospital Clínica Nova.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vitamine D3 supplementation1. The supplementation treatment will consist of prescribing vitamin D3 consumption of 4000 U 13 single dose tablets each month (52,000 IU). | Dietary supplement | serum vitamin D levels >20ng/ml (Group 1), serum vitamin D3 levels < 20ng/ml (Group3) |
| Diet and sun exposure2. Hygienic-dietary recommendations will consist of 2 steps 1. Sun exposure at least 10 minutes a day from 10: 00-6: 00 pm 2. Consumption of foods rich in vitamin D: milk, fish, almonds, mushrooms | Dietary supplement | serum vitamin D levels >20ng/ml ( Group 2) |
Primary outcome
Number of participants with Covid-19 Infection with Vitamin D3 > 20ng/ml
Time frame: 6 months
Evaluate the number of patients that get infected by COVID-19 during study period with vitamin D3 levels >20ng/ml that receive supplementation or diet and hygiene measures
Number of participants with Influenza H1N1 infection with Vitamin D3 > 20ng/ml
Time frame: 6 months
Evaluate the number of patients that get infected by H1N1 infection with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
Number of participants with Influenza A infection with Vitamin D3 > 20ng/ml
Time frame: 6 months
Evaluate the number of patients that get infected by Influenza A with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
Number of participants with Influenza B infection with Vitamin D3 > 20ng/ml
Time frame: 6 months
Evaluate the number of patietns that get infected by Influenza B with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
4 secondary outcomes
Number of participants with Covid-19 Infection with Vitamin D3 < 20ng/ml
Time frame: 6 months
Number of participants with H1N1 infection Infection with Vitamin D3 < 20ng/ml
Time frame: 6 months
Number of participants with influenza A Infection with Vitamin D3 < 20ng/ml
Time frame: 6 months
Number of participants with influenza B Infection with Vitamin D3 < 20ng/ml
Time frame: 6 months
Results and safety
The study was stopped early (reason given: patients enrolled got vaccinated vs COVID-19 and Influenza). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 32156327Spiteri G, Fielding J, Diercke M, Campese C, Enouf V, Gaymard A, Bella A, Sognamiglio P, Sierra Moros MJ, Riutort AN, Demina YV, Mahieu R, Broas M, Bengner M, Buda S, Schilling J, Filleul L, Lepoutre A, Saura C, Mailles A, Levy-Bruhl D, Coignard B, Bernard-Stoecklin S, Behillil S, van der Werf S, Valette M, Lina B, Riccardo F, Nicastri E, Casas I, Larrauri A, Salom Castell M, Pozo F, Maksyutov RA, Martin C, Van Ranst M, Bossuyt N, Siira L, Sane J, Tegmark-Wisell K, Palmerus M, Broberg EK, Beaute J, Jorgensen P, Bundle N, Pereyaslov D, Adlhoch C, Pukkila J, Pebody R, Olsen S, Ciancio BC. First cases of coronavirus disease 2019 (COVID-19) in the WHO European Region, 24 January to 21 February 2020. Euro Surveill. 2020 Mar;25(9):2000178. doi: 10.2807/1560-7917.ES.2020.25.9.2000178.
- Background: PubMed 33593830Griffin G, Hewison M, Hopkin J, Kenny RA, Quinton R, Rhodes J, Subramanian S, Thickett D. Perspective: Vitamin D supplementation prevents rickets and acute respiratory infections when given as daily maintenance but not as intermittent bolus: implications for COVID-19. Clin Med (Lond). 2021 Mar;21(2):e144-e149. doi: 10.7861/clinmed.2021-0035. Epub 2021 Feb 16.
- Background: PubMed 34764797Dzopalic T, Bozic-Nedeljkovic B, Jurisic V. The role of vitamin A and vitamin D in modulation of the immune response with a focus on innate lymphoid cells. Cent Eur J Immunol. 2021;46(2):264-269. doi: 10.5114/ceji.2021.103540. Epub 2021 Aug 7.
- Background: PubMed 32755992Bilezikian JP, Bikle D, Hewison M, Lazaretti-Castro M, Formenti AM, Gupta A, Madhavan MV, Nair N, Babalyan V, Hutchings N, Napoli N, Accili D, Binkley N, Landry DW, Giustina A. MECHANISMS IN ENDOCRINOLOGY: Vitamin D and COVID-19. Eur J Endocrinol. 2020 Nov;183(5):R133-R147. doi: 10.1530/EJE-20-0665.
- Background: PubMed 32377965Ilie PC, Stefanescu S, Smith L. The role of vitamin D in the prevention of coronavirus disease 2019 infection and mortality. Aging Clin Exp Res. 2020 Jul;32(7):1195-1198. doi: 10.1007/s40520-020-01570-8. Epub 2020 May 6.
- Background: PubMed 34273098Oristrell J, Oliva JC, Casado E, Subirana I, Dominguez D, Toloba A, Balado A, Grau M. Vitamin D supplementation and COVID-19 risk: a population-based, cohort study. J Endocrinol Invest. 2022 Jan;45(1):167-179. doi: 10.1007/s40618-021-01639-9. Epub 2021 Jul 17.
- Background: PubMed 35113901Dror AA, Morozov N, Daoud A, Namir Y, Yakir O, Shachar Y, Lifshitz M, Segal E, Fisher L, Mizrachi M, Eisenbach N, Rayan D, Gruber M, Bashkin A, Kaykov E, Barhoum M, Edelstein M, Sela E. Pre-infection 25-hydroxyvitamin D3 levels and association with severity of COVID-19 illness. PLoS One. 2022 Feb 3;17(2):e0263069. doi: 10.1371/journal.pone.0263069. eCollection 2022.
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- Background: PubMed 35004568Chiodini I, Gatti D, Soranna D, Merlotti D, Mingiano C, Fassio A, Adami G, Falchetti A, Eller-Vainicher C, Rossini M, Persani L, Zambon A, Gennari L. Vitamin D Status and SARS-CoV-2 Infection and COVID-19 Clinical Outcomes. Front Public Health. 2021 Dec 22;9:736665. doi: 10.3389/fpubh.2021.736665. eCollection 2021.
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- Individual participant dataSharing planned: Yes
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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.
Arnulfo Gonzalez-Cantu, MD principal investigator
Hospital Clinica Nova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamine D3 supplementation and Diet and sun exposure in people with Covid19 and Influenza A, run by Hospital Clinica Nova 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 9 inclusion and 0 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: stopped early, as of the sponsor's last update on 14 Apr 2022. 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. 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 was stopped early (reason given: patients enrolled got vaccinated vs COVID-19 and Influenza). Results are not available in the source record.
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?
Number of participants with Covid-19 Infection with Vitamin D3 > 20ng/ml (time frame: 6 months). The study lists 4 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 NCT04810949, which also lists 14 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 14 Apr 2022.