NCT01815047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

March 11, 2013

Last Update Submit

October 25, 2019

Conditions

InflammationInfection

Keywords

Vitamin DPregnancyInflammationInfectionPlacentaCytokineMicrobiome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in maternal vitamin D status and inflammatory markers in serum

    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

    Mid-gestation and delivery

Other Outcomes (2)

  • Vitamin D and placental inflammation

    Delivery

  • Vaginal microbiome profile

    Mid to late gestation

Study Arms (2)

200 IU Vitamin D3

EXPERIMENTAL

A singular daily dose of 200 IU vitamin D3

Dietary Supplement: Vitamin D3 Supplementation

2000 IU Vitamin D3

EXPERIMENTAL

A singular daily dose of 2000 IU vitamin D3

Dietary Supplement: Vitamin D3 Supplementation

Interventions

Vitamin D3 SupplementationDIETARY_SUPPLEMENT
200 IU Vitamin D32000 IU Vitamin D3

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female adolescents between 13 and 18 years of age
  • Between 12 and \< 30 weeks pregnant

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Highland Hospital

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Best CM, Pressman EK, Queenan RA, Cooper E, Vermeylen F, O'Brien KO. Gestational Age and Maternal Serum 25-hydroxyvitamin D Concentration Interact to Affect the 24,25-dihydroxyvitamin D Concentration in Pregnant Adolescents. J Nutr. 2018 Jun 1;148(6):868-875. doi: 10.1093/jn/nxy043.

    PMID: 29796622DERIVED

MeSH Terms

Conditions

InflammationInfections

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kimberly O'Brien, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 20, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2015

Study Completion

May 1, 2019

Last Updated

October 28, 2019

Record last verified: 2019-10

Locations

US(1)