Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy

October 25, 2019 updated by: Cornell University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Rochester, New York, United States, 14642
        • Highland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 200 IU Vitamin D3
A singular daily dose of 200 IU vitamin D3
EXPERIMENTAL: 2000 IU Vitamin D3
A singular daily dose of 2000 IU vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation
Time Frame: Entry into study, mid-gestation and delivery
Maternal calciotropic hormones (25(OH)D, 1,25(OH)2D, 24,25(OH)2D, and PTH) and inflammatory cytokines (CRP, interleukin [IL]-6 and IL-10 and tumor necrosis factor [TNF]-alpha) will be measured at entry into the study and again at 23-28 weeks gestation and delivery after treatment with 200 IU or 2000 IU D3/d. These measures will be compared to inflammatory processes and infections reported in medical records across pregnancy.
Entry into study, mid-gestation and delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maternal vitamin D status and inflammatory markers in serum
Time Frame: Mid-gestation and delivery
In a retrospective analysis, inflammatory cytokines (CRP, IL- 6 and IL-10 and TNF-alpha) in archived serum collected from a cohort of 158 adolescents that were longitudinally followed across pregnancy both at mid-gestation and at delivery will be related to 25-hydroxyvitamin D (25(OH)D), 1,25- dihydroxyvitamin D (1,25(OH)2D) and parathyroid hormone (PTH) and medically treated infections and inflammatory conditions abstracted from medical records.
Mid-gestation and delivery
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
Time Frame: Mid-gestation and delivery
Mid-gestation and delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D and placental inflammation
Time Frame: Delivery
Genome-wide microarray studies of mRNA and miRNA in a subset of placental tissue from adolescents with insufficient (<15 ng/mL) and sufficient vitamin D status (>30 ng/mL) will be screened for differential regulation of genes and gene networks involved in inflammatory processes.
Delivery
Vaginal microbiome profile
Time Frame: Mid to late gestation
Vitamin D supplementation (200 IU/d D3 and 2000 IU/d D3), dietary intake, 25-hydroxyvitamin D (25(OH)D), 1,25-dihydroxyvitamin D (1,25 (OH)2D), parathyroid hormone(PTH), inflammatory cytokines (CRP, IL- 6 and IL-10 and TNF-alpha) and infection (from medical records) will be related to vaginal microbiome profile.
Mid to late gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (ESTIMATE)

March 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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