Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • COVID-19
  • Pregnancy Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, non-blinded controlled trialMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Researchers propose a randomized, non-blinded clinical trial in pregnant women recruited at the obstetrics and gynecology service of the Virgen de las Nieves University Hospital Granada during the appointment of the first gynecological control visit (weeks 10-12 of pregnancy). The woman participatin...

Researchers propose a randomized, non-blinded clinical trial in pregnant women recruited at the obstetrics and gynecology service of the Virgen de las Nieves University Hospital Granada during the appointment of the first gynecological control visit (weeks 10-12 of pregnancy). The woman participating in the study will be assigned to two randomized follow-up groups, intervention group that will be supplied with 2.000 IU of vitamin D and control group with 400 IU of vitamin D, in turn they will be allocated to a risk group and healthy group. Participants will take the supplementation from 10-12 weeks of gestation to delivery. The frequency of gybecological visits will coincide with their routine prenatal visits: weeks 10-12, weeks 20-24 and weeks 34-35 of gestation. During the entire duration of the study, pregnant women will be in touch with the health professionals through routine hospital controls. The present study was approved by the Ethics Commitee CEIM/CEI of Granada, Spain.

Tracking Information

NCT #
NCT04825093
Collaborators
Not Provided
Investigators
Not Provided