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Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19

NCT04825093 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-03-22

No results posted yet for this study

Summary

Vitamin D defiency during pregnancy is a major public health problem worldwide; In Spain, the average intake of vitamin D is lower than recommendations in an elevated percentage of the population, ranging from 50 to 95%, according to the Spanish Society of Community Nutrition (SENC). Recent research suggests that adverse pregnancy outcomes are associated to vitain D deficiency. Associated comorbidities are further complicated by the SARS-COV-2 Pandemic. Few studies have assessed the transmission of SARS-CoV-2 antibodies from mothers who have had the disease or have been vaccinated to their newborns, either at birth or during breastfeeding, or how vitamin D concentration influences the generation of such an immune response. The COVID-19 pandemic is a dynamic situation. Peer-reviewed studies in large study cohorts point to a clear relationship between prevalence and severity of COVID-19 and vitamin D deficiency.

Conditions

  • Pregnancy Complications
  • Covid19

Interventions

DIETARY_SUPPLEMENT

Vitamin D supplementation in pregnant women

Intervention group will be administered 1,000 UI of vitamin D and a control group will be administered 400 UI of vitamin D. Participants will take the supplementation from the enrollment to delivery.

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Principal Investigators

  • María José MJ Aguilar Cordero, PhD · University of Granada (UGR)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2023-10-30
Completion
2024-12-30

Countries

  • Spain

Study Locations

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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 NCT04825093 on ClinicalTrials.gov