TerminatedNot Applicable

Vitamine D3 Supplementation in Patients With Serum Values +/- 20ng/ml

Stopped: patients enrolled got vaccinated vs COVID-19 and Influenza

Mexico41 participantsStarted 2020-08-05

Plain-language 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. 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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: * Serum Vitamin D levels\> 100ng / ml * Previous consumption of supplements containing Vitamin D3 * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with Covid-19 Infection with Vitamin D3 > 20ng/ml

Timeframe: 6 months

Number of participants with Influenza H1N1 infection with Vitamin D3 > 20ng/ml

Timeframe: 6 months

Number of participants with Influenza A infection with Vitamin D3 > 20ng/ml

Timeframe: 6 months

Number of participants with Influenza B infection with Vitamin D3 > 20ng/ml

Timeframe: 6 months

Trial details

NCT IDNCT04810949

SponsorHospital Clinica Nova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-01

View on ClinicalTrials.gov More Covid19 trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with Covid-19 Infection with Vitamin D3 > 20ng/ml

Timeframe: 6 months

Number of participants with Influenza H1N1 infection with Vitamin D3 > 20ng/ml

Timeframe: 6 months

Number of participants with Influenza A infection with Vitamin D3 > 20ng/ml

Timeframe: 6 months

Number of participants with Influenza B infection with Vitamin D3 > 20ng/ml

Timeframe: 6 months