- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01815047
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
Intervention / Treatment
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.
Sponsor
Collaborators
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 1201002753
- USDA 2012-67017-30216 (OTHER_GRANT: USDA 2012-67017-30216)
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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