This trial is active, not recruiting.

Conditions inflammation, infection
Treatment vitamin d3 supplementation
Sponsor Cornell University
Collaborator University of Rochester
Start date December 2012
End date December 2015
Trial size 85 participants
Trial identifier NCT01815047, IRB 1201002753, USDA 2012-67017-30216


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
A singular daily dose of 200 IU vitamin D3
vitamin d3 supplementation
A singular daily dose of 2000 IU vitamin D3
vitamin d3 supplementation

Primary Outcomes

Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation
time frame: Entry into study, mid-gestation and delivery

Secondary Outcomes

Change in maternal vitamin D status and inflammatory markers in serum
time frame: Mid-gestation and delivery

Eligibility Criteria

Female participants from 13 years up to 18 years old.

Inclusion Criteria: - Female adolescents between 13 and 18 years of age - Between 12 and < 30 weeks pregnant Exclusion Criteria: - 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

Additional Information

Official title Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
Principal investigator Kimberly O'Brien, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Cornell University.