Clinical trial NCT01815047: Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
Official title: Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Infection
Keywords: Vitamin D
Pregnancy
Inflammation
Infection
Placenta
Cytokine
Microbiome
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: University of Rochester
First posted: 2013-03-20
Enrollment: 85
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation
timeFrame: Entry into study, mid-gestation and delivery
Secondary outcomes:
measure: Change in maternal vitamin D status and inflammatory markers in serum
timeFrame: Mid-gestation and delivery
measure: 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
timeFrame: Mid-gestation and delivery
Other outcomes:
measure: Vitamin D and placental inflammation
timeFrame: Delivery
measure: Vaginal microbiome profile
timeFrame: Mid to late gestation
Locations:
city: Rochester
country: United States
facility: Highland Hospital
state: New York
Study officials:
affiliation: Cornell University
name: Kimberly O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Best CM, Pressman EK, Queenan RA, Cooper E, Vermeylen F, O'Brien KO. Gestational Age and Maternal Serum 25-hydroxyvitamin D Concentration Interact to Affect the 24,25-dihydroxyvitamin D Concentration in Pregnant Adolescents. J Nutr. 2018 Jun 1;148(6):868-875. doi: 10.1093/jn/nxy043.