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Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy

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ClinicalTrials.gov Identifier: NCT01815047
Recruitment Status : Completed
First Posted : March 20, 2013
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammation Infection Dietary Supplement: Vitamin D3 Supplementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy
Study Start Date : December 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: 200 IU Vitamin D3
A singular daily dose of 200 IU vitamin D3
Dietary Supplement: Vitamin D3 Supplementation
Experimental: 2000 IU Vitamin D3
A singular daily dose of 2000 IU vitamin D3
Dietary Supplement: Vitamin D3 Supplementation



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 ]

Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815047


Locations
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United States, New York
Highland Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
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Principal Investigator: Kimberly O'Brien, PhD Cornell University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01815047    
Other Study ID Numbers: IRB 1201002753
USDA 2012-67017-30216 ( Other Grant/Funding Number: USDA 2012-67017-30216 )
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Keywords provided by Cornell University:
Vitamin D
Pregnancy
Inflammation
Infection
Placenta
Cytokine
Microbiome
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Inflammation
Pathologic Processes
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents