Randomised Clinical Trial of Vitamin D Supplementation in Pregnant Women and Prevalence of Covid-19 Immunity.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Prevalence of preterm birth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prevalence of preterm birth
时间窗: 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 gestational diabetes mellitus
时间窗: 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
时间窗: 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).
Prevalence of preeclampsia
时间窗: 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.
Blood analysis of serum concentrations of 25-hydroxyvitamin D
时间窗: 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.
次要结局
- Birth Weight(Postpartum)
- Miscarriage(six months to 12 months post-partum.)
- Psychomotor development of offspring(Postpartum to 6 month)
- Neonatal immunity(Postpartum)
研究者
María José Aguilar Cordero
Professor of Nursing
Universidad de Granada