Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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

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Inflammation Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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200 IU Vitamin D3

A singular daily dose of 200 IU vitamin D3

Group Type EXPERIMENTAL

Vitamin D3 Supplementation

Intervention Type DIETARY_SUPPLEMENT

2000 IU Vitamin D3

A singular daily dose of 2000 IU vitamin D3

Group Type EXPERIMENTAL

Vitamin D3 Supplementation

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin D3 Supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes