NCT01815047

Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Cornell University · Academic / Other
• Sex: Female
• Age: 13 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Inflammation
• Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3 Supplementation

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-12-01
• Completion: 2019-05-01
• First posted: 2013-03-20
• Last updated: 2019-10-28

Locations

1 site across 1 country: United States