Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy

Cornell University

Status: Completed

Conditions: Infection; Inflammation

Treatments: Dietary Supplement: Vitamin D3 Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01815047

IRB 1201002753

USDA 2012-67017-30216 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: Female

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 2 patient groups

200 IU Vitamin D3

Experimental group

Description:

A singular daily dose of 200 IU vitamin D3

Treatment:

Dietary Supplement: Vitamin D3 Supplementation

2000 IU Vitamin D3

Experimental group

Description:

A singular daily dose of 2000 IU vitamin D3

Treatment:

Dietary Supplement: Vitamin D3 Supplementation