Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation
研究概览
简要总结
The goal of this study is to characterize the function and efficacy of the bioactive nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The three specific aims of this study are 1) To address the impact of maternal vitamin D status on inflammation and infections across pregnancy using retrospective data, 2) To address the impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D status during pregnancy on inflammatory mediators at the level of the placenta.
详细描述
Archived serum collected from 158 adolescents at mid-gestation (approximately 26 weeks) and delivery will be analyzed for inflammatory cytokines. The impact of these inflammatory markers will be assessed by comparing the data to measures of vitamin D (25(OH)D, calcitriol and parathyroid hormone) and infections and inflammatory complications abstracted from medical charts. Placental samples were collected from a subset (n=132) of these pregnant teens and these tissues will be analyzed using genome wide microarray of messenger ribonucleic acid (mRNA) and microRNA (miRNA) related to inflammatory processes. A separate group of pregnant adolescents (n=140) will be recruited at entry into prenatal care for a vitamin D supplementation trial. Teens will be randomly assigned to one of two supplements (200 IU D3/d vs. 2000 IU D3/d). Similar to the retrospective analysis, maternal calciotropic hormones and inflammatory cytokines will be assessed at entry into the study, mid-gestation (23-28 weeks) and at delivery. Inflammatory processes and infections reported across pregnancy will be evaluated in relation to vitamin D status and inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female adolescents between 13 and 18 years of age
- •Between 12 and < 30 weeks pregnant
排除标准
- •HIV-infection
- •Eating disorders
- •Malabsorption diseases
- •Diabetes mellitus
- •Gestational diabetes
- •Pregnancy induced hypertension or elevated diastolic blood pressure (>110)
- •Steroid use
- •Substance abuse history
- •Taking medications known to influence Ca or vitamin D status
- •Diagnosis of elevated blood lead concentrations during childhood
- •Smokes tobacco
研究组 & 干预措施
200 IU Vitamin D3
A singular daily dose of 200 IU vitamin D3
干预措施: Vitamin D3 Supplementation (Dietary Supplement)
2000 IU Vitamin D3
A singular daily dose of 2000 IU vitamin D3
干预措施: Vitamin D3 Supplementation (Dietary Supplement)
结局指标
主要结局
Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation
时间窗: Entry into study, mid-gestation and delivery
Maternal calciotropic hormones (25(OH)D, 1,25(OH)2D, 24,25(OH)2D, and PTH) and inflammatory cytokines (CRP, interleukin \[IL\]-6 and IL-10 and tumor necrosis factor \[TNF\]-alpha) will be measured at entry into the study and again at 23-28 weeks gestation and delivery after treatment with 200 IU or 2000 IU D3/d. These measures will be compared to inflammatory processes and infections reported in medical records across pregnancy.
次要结局
- Change in maternal vitamin D status and inflammatory markers in serum(Mid-gestation and delivery)
- Association of maternal vitamin D status (25(OH)D concentration with longitudinal change in 1,25(OH)2D, PTH, 24,25(OH)2D,and the vitamin D metabolite ratio(Mid-gestation and delivery)