Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19 (VID-WOMAN)

• ClinicalTrials.gov Identifier: NCT04825093
• Recruitment Status: Not yet recruiting
• First Posted: April 1, 2021
• Last Update Posted: April 1, 2021
• Sponsor: Universidad de Granada
• Information provided by (Responsible Party): María José Aguilar Cordero, Universidad de Granada

Study Description

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. Several reviews consider that vitamin D reduces the risk of viral infections and might play a role in preventing acute respiratory distress syndrome that is the most frequent cause of mortality due to COVID-19.

In the light of the effects of vitamin D deficiency during pregnancy, the researchers propose to use vitamin D supplementation as a therapeutic tool in the prevention of these adverse effects. The investigators aim at studying the role of vitamin D in reducing the risk of viral and respiratory tract infections such as COVID-19

Condition or disease	Intervention/treatment	Phase
Pregnancy Complications; Covid19	Dietary Supplement: Vitamin D supplementation in pregnant women	Not Applicable

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 10-12 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, non-blinded controlled trial
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Clinical Trial With Vitamin D Supplementation in Pregnant Women and Prevalence of COVID-19
• Estimated Study Start Date: May 1, 2021
• Estimated Primary Completion Date: October 30, 2022
• Estimated Study Completion Date: December 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention group; Women allocated to this group will be supplemented with 2,000 UI of vitamin D3.	Dietary Supplement: Vitamin D supplementation in pregnant women; Intervention group will be administered 2,000 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.
Active Comparator: Control group; The control group will consist of pregnant women supplemented with 400 UI of vitamin D3.	Dietary Supplement: Vitamin D supplementation in pregnant women; Intervention group will be administered 2,000 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.

Outcome Measures

Primary Outcome Measures :

1. Serum concentration of 25-hydroxyvitamin D [ Time Frame: 10-12 weeks of gestation to postpartum. ]
   The research group aims at evaluating the efficacy of vitamin D supplementation at modying maternal levels of serum 25-hydroxyvitamin D during pregnancy
2. Prevalence of preterm birth [ Time Frame: Postpartum. ]
   Cases of preterm birth (<37 weeks of gestation) will be evaluated in both groups of study.
3. Prevalence of preeclampsia [ Time Frame: 20 weeks of gestation to postpartum. ]
   Cases of preeclampsia defined following the ISSHP recommendations will be evaluated in both groups of study.
4. Prevalence of gestational diabetes mellitus [ Time Frame: 10-12 weeks of gestation to postpartum. ]
   Cases of Gestational diabetes mellitus defined based on criteria from the American Diabetes Association will be evaluated.
5. Prevalence of COVID-19 [ Time Frame: 10-12 weeks of gestation to postpartum. ]
   Prevalence of COVID-19 in both groups of study will be assessed using a PCR test. Serological analysis will be conducted at recrutment to know base status.

Secondary Outcome Measures :

1. Severity of COVID-19 [ Time Frame: 10-12 Weeks of gestation to postpartum ]
   Severity of the disease based on respiratory symtoms, hospital admission rates and recovery/death rates
2. Miscarriage [ Time Frame: six months to 12 months post-partum. ]
   Cases of miscarriage, fetal death and stillbirths in the groups of study.
3. Neonatal immunity [ Time Frame: Postpartum ]
   Serum levels of IgG and IgM against SARS-CoV-2 measured using ab rapid tests immunochromatography in immunized mothers.
4. Birth Weight [ Time Frame: Postpartum ]
   Cases of low birth weight (<2,500 g) and small-for-gestational-age (based on specific population percentiles) will be evaluated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

The inclusion criteria corresponding to the risk group consist of:

• Participants that present hypertension or diabetes mellitus before pregnancy
• BMI >35
• Family history of preeclampsia or diabetes
• Macrosomic previous baby
• BMI< 20
• History of pretem delivery
• Previous intrauterine growth restriction or gestational mellitus diabetes history
• Maternal age <16 years or > 40 years
• History maternal infection.

The inclusion criteria for healthy participants are:

• Patients between 10-12 weeks of gestation
• BMI between 20 to 30.

Exclusion Criteria:

• Exclusion criteria are:
• Participants consuming multivitamin complexes
• Unable to sign inform consent.

Contacts and Locations

Locations

Spain

Maria Jose Aguilar Cordero

Granada, Spain, 18010

Contact: Maria Jose MJ Aguilar Cordero, PhD 657841751 mariajaguilar@telefonica.net

Sponsors and Collaborators

Universidad de Granada

More Information

• Responsible Party: María José Aguilar Cordero, Professor of Nursing, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT04825093
• Other Study ID Numbers: SVD-COVID-2020
• First Posted: April 1, 2021
• Last Update Posted: April 1, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María José Aguilar Cordero, Universidad de Granada:

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

Additional relevant MeSH terms:

COVID-19; Pregnancy Complications; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vitamin D; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents