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Vitamin D Dynamics in Women

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ClinicalTrials.gov Identifier: NCT02705287
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University

Brief Summary:
The goal of this pilot project is to utilize stable isotopically labeled vitamin D3 and state of the art mass spectrometric methodology to assess vitamin D dynamics during pregnancy in relation to calcitropic hormone status at this key life stage. At the conclusion of this study, the investigators will have obtained novel information on the absorption and utilization of vitamin D in women and determined if maternal vitamin D3 or maternal 25(OH)D3, or both, can be transferred across the placenta to the fetus. The long-term goal is to better understand the unique metabolism of vitamin D during pregnancy.

Condition or disease Intervention/treatment
Pregnancy Other: Vitamin D dynamics-pregnant Other: Vitamin D dynamics-nonpregnant Other: Delivery-placental transfer Other: Delivery-Vitamin D Other: Delivery-25(OH) Vitamin D

Detailed Description:

Nearly 30% of US women are either vitamin D insufficient or deficient. Vitamin D inadequacy during gestation is increasingly linked to adverse birth outcomes including preterm birth, the risk of cesarean section and placental and pregnancy-associated infections. At this time the Institute of Medicine (IOM) has not advocated any increase in vitamin D intake across gestation but this remains controversial in large part due to insufficient information on the basic physiology of vitamin D. Pregnancy induces dramatic changes in regulation of vitamin D. The investigators hypothesize that increased maternal, placental, and fetal vitamin D requirements during late gestation will result in an increase in vitamin D absorption and a decrease in the half-life of both vitamin D3 and 25-hydroxyvitamin D. The fetus is entirely dependent on maternal vitamin D to meet its requirements for this nutrient. Maternal vitamin D is thought to be passively transferred across the placenta to the fetus given that neonatal concentrations of 25(OH)D are at least 20-30% lower than maternal 25(OH)D concentrations. To date, much of what is known about vitamin D absorption and utilization in humans has been extrapolated from early radiotracer studies in adult men and non-pregnant women and there are no in vivo data to determine if maternal vitamin D3 or maternal 25(OH)D3, or both, can be transferred across the placenta to the fetus

The specific aims of this project are to:

  1. Obtain pilot data on the absorption of vitamin D3 in non-pregnant and pregnant women, following oral dosing with deuterated vitamin D3
  2. Obtain pilot data on the dynamics of the conversion of vitamin D3 into 25-hydroxyvitamin D3, following dosing with oral deuterated vitamin D3
  3. Estimate the serum half-life of vitamin D3 and 25-hydroxyvitamin D3 in non-pregnant and pregnant women
  4. Evaluate the absorption of vitamin D3 in late gestation and evaluate the concentrations of these forms of vitamin D in the cord blood at birth
  5. Evaluate the ability of the placenta to rapidly transfer maternally absorbed vitamin D3 to the fetus at term
  6. Evaluate the ability of the placenta to rapidly transfer maternally absorbed 25(OH)D3 to the fetus at term

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Vitamin D Dynamics in Pregnant Women and Non-Pregnant Women of Reproductive Age
Study Start Date : July 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
Vitamin D dynamics-pregnant
Pregnant women recruited to measure Vitamin D dynamics during pregnancy.
Other: Vitamin D dynamics-pregnant
tracer dose of deuterated vitamin D3

Vitamin D dynamics-nonpregnant
Non-pregnant women recruited to measure Vitamin D dynamics.
Other: Vitamin D dynamics-nonpregnant
tracer dose of deuterated vitamin D3

Delivery-placental transfer
Pregnant women planning to deliver by scheduled c-section who will be dosed with vitamin D3 in late gestation (week 36-38).
Other: Delivery-placental transfer
tracer dose of deuterated vitamin D3 to women in late gestation

Delivery-Vitamin D
Pregnant women will be dosed with vitamin D3 at term when they come in for their pre-surgical appointments prior to their scheduled c-section
Other: Delivery-Vitamin D
women will be dosed with deuterated vitamin D3 at term when they come in for their pre-surgical appointments prior to their scheduled c-section

Delivery-25(OH) Vitamin D
Pregnant women will be dosed with 25(OH)D3 when they come in for their pre-surgical appointments
Other: Delivery-25(OH) Vitamin D
women will be dosed with deuterated 25(OH)D3 when they come in for their pre-surgical appointments




Primary Outcome Measures :
  1. Serum vitamin D3 half-life [ Time Frame: Across 30 days study period ]
    A baseline blood sample (20 mL) will be obtained for analysis of the baseline concentrations of calcitropic hormones and indicators of vitamin D status. Each woman will be asked to ingest one quarter piece of toast onto which a dose of 25 μg (1000 IU) of [6,19,19-d3]-vitamin D3 has been added. Women will return to the on Day 2, 8, 12, 16, 20 and 30 (± 2 days) for an additional blood sample (10 mL each) to assess the disappearance of the deuterated D3.

  2. Forms of vitamin D can be transferred across the placenta [ Time Frame: Across 1-2 days study period ]
    At delivery a sample of cord blood and placental tissue will be obtained to evaluate the presence of labeled vitamin D or its metabolites in the neonate at birth and in the placental tissue


Secondary Outcome Measures :
  1. Serum 25-hydroxyvitamin D3 half-life [ Time Frame: Across 30 days study period ]
    A baseline blood sample (20 mL) will be obtained for analysis of the baseline concentrations of calcitropic hormones and indicators of vitamin D status. Each woman will be asked to ingest one quarter piece of toast onto which a dose of 25 μg (1000 IU) of [6,19,19-d3]-vitamin D3 has been added. Women will return to the on Day 2, 8, 12, 16, 20 and 30 (± 2 days) for an additional blood sample (10 mL each) to examine the appearance and subsequent disappearance of deuterated 25(OH)D3.


Biospecimen Retention:   Samples With DNA
Serum samples and extracted DNA sample (biospecimen retention will be both with and without DNA)


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women and non-pregnant women of reproductive age
Criteria

Inclusion Criteria (Non-pregnant and pregnant participants participants):

  • Caucasian race
  • Age 19-35
  • Body mass index (BMI) or pre-pregnancy BMI (If currently pregnant) < 28 kg/m2

Inclusion Criteria (Additional criteria for pregnant participants):

  • Singleton pregnancy
  • 20 to <36 weeks pregnant during study participation
  • No pregnancy complications
  • Planning to delivery by scheduled c-section (if participating in the placental transfer study Aims 4-6)

Exclusion Criteria (Non-pregnant and pregnant participants):

  • BMI or pre-pregnancy BMI ≥ 28 kg/m2
  • Human immunodeficiency virus (HIV) infection
  • Diagnosed eating disorder
  • Malabsorption disease
  • Diabetes
  • Elevated diastolic blood pressure (>110 mm/Hg)
  • Steroid use
  • Substance abuse history
  • Current use of medications known to influence vitamin D or calcium homeostasis
  • Plans to travel to lower latitude during the 20-day study period
  • Plans to become pregnant during the study period (non-pregnant only)
  • Refuses to discontinue tanning bed use during study period
  • Refuses to discontinue vitamin or mineral supplement use during study period (non-pregnant only)

Exclusion Criteria (Additional criteria for pregnant participants):

  • Gestational diabetes
  • Pregnancy hypertension

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): NCT02705287


Locations
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United States, New York
University of Rochester, 518 Hylan Building
Rochester, New York, United States, 14627
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
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Principal Investigator: Kimberly O. O'Brien, PhD Cornell University
Principal Investigator: Eva Pressman, MD University of Rochester
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT02705287    
Other Study ID Numbers: IRB # 1509005821
RSRB00057617 ( Other Identifier: University of Rochester )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cornell University:
vitamin D
half life
kinetics
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents