Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy

Inflammation Clinical Trial

Official title:

Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815047
• Other study ID #: IRB 1201002753
• Secondary ID: USDA 2012-67017-
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: May 2019

Study information

• Verified date: October 2019
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Inflammation

Intervention

Dietary Supplement:
• Vitamin D3 Supplementation

Locations

Country	Name	City	State
United States	Highland Hospital	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vitamin D and placental inflammation	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
Other	Vaginal microbiome profile	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
Primary	Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation	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	Change in maternal vitamin D status and inflammatory markers in serum	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
Secondary	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		Mid-gestation and delivery