Pregnancy ComplicationsD-WOMANNCT04825093
Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19
A study testing Vitamin D supplementation in pregnant women in people with Pregnancy Complications and Covid19, run by Universidad de Granada at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Covid19
- What is being tested?
- Vitamin D supplementation in pregnant women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 29 Sep 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Maria Jose Aguilar Cordero
Granada, 18010
Maria Jose MJ Aguilar Cordero, PhD, 657841751, mariajaguilar@telefonica.net
Ana María AM Rojas Carvajal, Pre-Doctor
About this study
Official title: Randomised Clinical Trial of Vitamin D Supplementation in Pregnant Women and Prevalence of Covid-19 Immunity.
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.
Read the 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.
- Conditions
- Pregnancy Complications, Covid19
- Being tested
- Vitamin D supplementation in pregnant women
- Keywords
- PREGNANCY, OUTCOMES, OFFSPRING, SUPPLEMENTATION, VITAMIN D, COVID19, SARS-COV-2
- Medical subject headings
- Pregnancy Complications, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementation in pregnant womenDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Women allocated to this group will be supplemented with 1,000 UI of vitamin D3. Receives: 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. Receives: Dietary Supplement: Vitamin D supplementation in pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 10-12 weeks of gestation to postpartum.
Secondary outcomes (4)
Miscarriage
Cases of miscarriage, fetal death and stillbirths in the groups of study will be assessed with respect to maternal vitamin D results.
Measured: six months to 12 months post-partum.
Neonatal immunity
A blood sample (IGG,IGM) will be taken from the neonate to determine the immunity against covid-19. Blood IGG results higher than 33.8 BAU/ml will mean positive for covid-19 immunity.
Measured: Postpartum
Birth Weight
All newborns born weighing less than 2,500 gr shall be considered as small-for-gestational-age (based on specific population percentiles) will be assessed with respect to maternal vitamin D results.
Measured: Postpartum
Psychomotor development of offspring
The psychomotor development of the newborn will be assessed using a validated questionnaire called Brunet-Lézine. This questionnaire will be answered by the mothers during the 6 months of the newborn's life.
Measured: Postpartum to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start29 Sep 2021
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, non-blinded controlled trial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María José Aguilar Cordero, Universidad de Granada
- Investigators
- María José MJ Aguilar Cordero, PhD, Principal investigator, University of Granada (UGR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825093
- Sponsor's protocol ID
- SVD-COVID-2020
- Acronym
- D-WOMAN
- Status last verified
- Mar 2023
- First submitted
- 2 Dec 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial of Vitamin D Supplementation in Pregnant Women and Prevalence of Covid-19 Immunity.
- ClinicalTrials.gov ID
- NCT04825093
- Acronym / sponsor ID
- D-WOMAN / SVD-COVID-2020
- Conditions
- Pregnancy Complications, Covid19
- Keywords
- PREGNANCY, OUTCOMES, OFFSPRING, SUPPLEMENTATION, VITAMIN D, COVID19, SARS-COV-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, non-blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Vitamin D supplementation in pregnant womenWomen allocated to this group will be supplemented with 1,000 UI of vitamin D3. |
| Control group | Active comparator | Dietary Supplement: Vitamin D supplementation in pregnant womenThe control group will consist of pregnant women supplemented with 400 UI of vitamin D3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplementation in pregnant womenIntervention 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. | Dietary supplement | Control group, Intervention group |
Primary outcome
Blood analysis of serum concentrations 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. Concentrations < 30 ng/ml shall be considered as low vitamin D concentration.
Prevalence of preterm birth
Time frame: Postpartum.
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.
Prevalence of preeclampsia
Time frame: 20 weeks of gestation to postpartum.
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.
Prevalence of gestational diabetes mellitus
Time frame: 10-12 weeks of gestation to postpartum.
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.
Prevalence of COVID-19 and COVID-19 inmunity
Time frame: 10-12 weeks of gestation to postpartum.
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).
4 secondary outcomes
Miscarriage
Time frame: six months to 12 months post-partum.
Neonatal immunity
Time frame: Postpartum
Birth Weight
Time frame: Postpartum
Psychomotor development of offspring
Time frame: Postpartum to 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María José MJ Aguilar Cordero, PhD principal investigator
University of Granada (UGR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplementation in pregnant women in people with Pregnancy Complications and Covid19, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria José MJ Aguilar Cordero, PhD (657841751, mariajaguilar@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood analysis of serum concentrations of 25-hydroxyvitamin D (time frame: 10-12 weeks of gestation to postpartum.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.