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

NCT04825093 | Unknown

• 1 other identifier: SVD-COVID-2020
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications; Covid19

Keywords

PREGNANCY; OUTCOMES; OFFSPRING; SUPPLEMENTATION; VITAMIN D; COVID19; SARS-COV-2

Outcome Measures

Primary Outcomes (5)

• Blood analysis of serum concentrations of 25-hydroxyvitamin D

  The research group aims at evaluating the efficacy of vitamin D supplementation at modying maternal levels of serum 25-hydroxyvitamin D during pregnancy. Concentrations \< 30 ng/ml shall be considered as low vitamin D concentration.

  10-12 weeks of gestation to postpartum.

• Prevalence of preterm birth

  All deliveries that take place at less than 37 weeks' gestation are considered preterm deliveries. Cases of preterm birth will be evaluated in both groups of study respect to maternal vitamin D results.

  Postpartum.

• Prevalence of preeclampsia

  The existence of a diagnosis of pre-eclampsia during pregnancy, defined following the ISSHP recommendations will be evaluated in both groups of study. This diagnosis will be obtained from a review of the patient's clinical history and will be assessed with respect to maternal vitamin D results.

  20 weeks of gestation to postpartum.

• Prevalence of gestational diabetes mellitus

  The existence of a diagnosis of Gestational diabetes mellitus defined based on criteria from the American Diabetes Association will be evaluated in both groups of study.This diagnosis will be obtained from a review of the patient's clinical history and will be assessed with respect to maternal vitamin D results.

  10-12 weeks of gestation to postpartum.

• Prevalence of COVID-19 and COVID-19 inmunity

  The prevalence of covid-19 and immunity to covid in the population will be calculated by the derivation of clinical blood test results for covid-19 antibodies (IGG, IGM).

  10-12 weeks of gestation to postpartum.

Secondary Outcomes (4)

• Miscarriage

  six months to 12 months post-partum.

• Neonatal immunity

  Postpartum

• Birth Weight

  Postpartum

• Psychomotor development of offspring

  Postpartum to 6 month

Study Arms (2)

Intervention group

EXPERIMENTAL

Women allocated to this group will be supplemented with 1,000 UI of vitamin D3.

Dietary Supplement: Vitamin D supplementation in pregnant women

Control group

ACTIVE COMPARATOR

The control group will consist of pregnant women supplemented with 400 UI of vitamin D3.

Dietary Supplement: Vitamin D supplementation in pregnant women

Interventions

Vitamin D supplementation in pregnant women DIETARY_SUPPLEMENT

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.

Control group; Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Maria Jose Aguilar Cordero

Granada, 18010, Spain

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; COVID-19

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• María José MJ Aguilar Cordero, PhD

  University of Granada (UGR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria José MJ Aguilar Cordero, PhD

CONTACT

657841751; mariajaguilar@telefonica.net

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: Professor of Nursing

Model Details: Randomized, non-blinded controlled trial

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: April 1, 2021
• Study Start: September 29, 2021
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)