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

NCT04810949 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-04-14

No results posted yet for this study

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

Interventions

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).

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

Sponsors & Collaborators

  • Hospital Clinica Nova

    lead OTHER

Principal Investigators

  • Arnulfo Gonzalez-Cantu, MD · Hospital Clinica Nova

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810949 on ClinicalTrials.gov