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

April 7, 2022 updated by: Maria Elena Romero Ibarguengoitia, Hospital Clinica Nova

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

  1. Supplementation with 52,000 units of vitamin D3 monthly
  2. 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:

  1. Serum levels of vitamin D (25-hydroxyvitamin D) will be measured in all medical personnel working at Hospital Clínica Nova.
  2. Patients with Vitamin D3<20ng/ml will be supplemented by primary care physician
  3. Treatment group will be randomized to patients with vitamin D3 levels >20ngml.
  4. Serum vitamin D levels will be monitored every 3 months
  5. 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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • San Nicolás De Los Garza, Nuevo León, Mexico, 66450
        • Hospital Clinica Nova de Monterrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: serum vitamin D levels >20ng/ml (Group 1)
Patients with serum vitamin D levels >20ng/ml that will receive Vitamin D supplementation
Dietary supplement: Vitamine D3 supplementation
1. The supplementation treatment will consist of prescribing vitamin D3 consumption of 4000 U 13 single dose tablets each month (52,000 IU).
Experimental: serum vitamin D levels >20ng/ml ( Group 2)
Patients with vitamin D levels >20ng/ml that will receive diet and hygiene measures
Dietary supplement: Diet and sun exposure

2. 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
Other: serum vitamin D3 levels < 20ng/ml (Group3)
Patients with Vitamin D levels<20ng/ml will receive vitamin D3 supplementation according to primary care discresion
Dietary supplement: Vitamine D3 supplementation
1. The supplementation treatment will consist of prescribing vitamin D3 consumption of 4000 U 13 single dose tablets each month (52,000 IU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
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
6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 according to primary care physician
6 months
Number of participants with H1N1 infection Infection with Vitamin D3 < 20ng/ml
Time Frame: 6 months
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
6 months
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 during study period with vitamin D3 levels <20ng/ml that receive supplementation according to primary care physician prescription
6 months
Number of participants with influenza B Infection with Vitamin D3 < 20ng/ml
Time Frame: 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinica Nova

Investigators

  • Principal Investigator: Arnulfo Gonzalez-Cantu, MD, Hospital Clinica Nova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamina D NOVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

during one year after the publication of the results

IPD Sharing Access Criteria

contacting corresponding author

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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