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

NCT04810949 | Terminated

• 1 other identifier: Vitamina D NOVA
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Influenza A; Influenza B; H1N1 Influenza

Outcome Measures

Primary 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 or diet and hygiene measures

  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

  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

  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

  6 months

Secondary Outcomes (4)

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

  6 months

• Number of participants with H1N1 infection Infection with Vitamin D3 < 20ng/ml

  6 months

• Number of participants with influenza A Infection with Vitamin D3 < 20ng/ml

  6 months

• Number of participants with influenza B Infection with Vitamin D3 < 20ng/ml

  6 months

Study Arms (3)

serum vitamin D levels >20ng/ml (Group 1)

EXPERIMENTAL

Patients with serum vitamin D levels \>20ng/ml that will receive Vitamin D supplementation

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

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

Dietary Supplement: Vitamine D3 supplementation

Interventions

Vitamine D3 supplementation DIETARY_SUPPLEMENT

1\. The supplementation treatment will consist of prescribing vitamin D3 consumption of 4000 U 13 single dose tablets each month (52,000 IU).

serum vitamin D levels >20ng/ml (Group 1); serum vitamin D3 levels < 20ng/ml (Group3)

Diet and sun exposure DIETARY_SUPPLEMENT

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

serum vitamin D levels >20ng/ml ( Group 2)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Serum Vitamin D levels\> 100ng / ml
• Previous consumption of supplements containing Vitamin D3
• Pregnancy

Sponsors & Collaborators

• Hospital Clinica Nova: lead

Study Sites (1)

Hospital Clinica Nova de Monterrey

San Nicolás de los Garza, Nuevo León, 66450, Mexico

Location

Related Publications (14)

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MeSH Terms

Conditions

COVID-19; Orthomyxoviridae Infections

Interventions

Diet

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Arnulfo Gonzalez-Cantu, MD

  Hospital Clinica Nova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/Research Director

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 23, 2021
• Study Start: August 5, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: during one year after the publication of the results
• Access Criteria: contacting corresponding author

Locations

ME (1)