Clinical trial NCT04825093: Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19
Official title: Randomised Clinical Trial of Vitamin D Supplementation in Pregnant Women and Prevalence of Covid-19 Immunity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Complications
Covid19
Keywords: PREGNANCY
OUTCOMES
OFFSPRING
SUPPLEMENTATION
VITAMIN D
COVID19
SARS-COV-2
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, non-blinded controlled trial
Primary purpose: PREVENTION

Brief 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.

Detailed 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 10-16 of pregnancy). The woman participating in the study will be assigned to two randomized follow-up groups, intervention group that will be supplied with 1.000 IU of vitamin D and control group with 400 IU of vitamin D.All pregnant women who want to participate in the study but do not wish to supplement, will be part of another group, the unsupplemented control group. Participants will take the supplementation from 10-16 weeks of gestation to delivery. The frequency of gybecological visits will coincide with their routine prenatal visits: weeks 10-16, weeks 20-24 and weeks 34-36 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.

Eligibility criteria: * INCLUSION CRITERIA:
* Pregnant women
* Over 18 years of age.
* Attendance at the hospital complex and intending to give birth in public centres in the province of Granada.
* With the capacity to understand and sign the informed consent form.
* EXCLUSION CRITERIA:
* Consumers of vitamin complexes.
* Co-infection with other infectious viruses or bacteria (HCV, HBV, HIV, among others).
* Severe respiratory symptoms that prevent participation in the study.

Primary outcomes:
measure: Blood analysis of serum concentrations of 25-hydroxyvitamin D
timeFrame: 10-12 weeks of gestation to postpartum.
measure: Prevalence of preterm birth
timeFrame: Postpartum.
measure: Prevalence of preeclampsia
timeFrame: 20 weeks of gestation to postpartum.
measure: Prevalence of gestational diabetes mellitus
timeFrame: 10-12 weeks of gestation to postpartum.
measure: Prevalence of COVID-19 and COVID-19 inmunity
timeFrame: 10-12 weeks of gestation to postpartum.
Secondary outcomes:
measure: Miscarriage
timeFrame: six months to 12 months post-partum.
measure: Neonatal immunity
timeFrame: Postpartum
measure: Birth Weight
timeFrame: Postpartum
measure: Psychomotor development of offspring
timeFrame: Postpartum to 6 month
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Maria Jose Aguilar Cordero
Study officials:
affiliation: University of Granada (UGR)
name: María José MJ Aguilar Cordero, PhD
role: PRINCIPAL_INVESTIGATOR
References: