Vitamin D Dynamics in Women

NCT02705287 | Recruiting DMC

• 2 other identifiers: IRB # 1509005821RSRB00057617
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this 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 relation to obesity and vitamin D binding protein genotype. At the conclusion of this study, the investigators will have obtained novel information on the absorption and utilization of vitamin D in women and the degree to which vitamin D utilization during pregnancy is impacted by genetic ancestry, vitamin D binding protein concentration and genotype and by excess adiposity. The long-term goal is to better understand the unique metabolism of vitamin D during pregnancy.

Conditions

Pregnancy

Keywords

vitamin D; half life; kinetics

Outcome Measures

Primary Outcomes (3)

• Impact of pregnancy on serum vitamin D absorption

  A baseline blood sample (20 mL) will be obtained for analysis of the baseline concentrations of indicators of vitamin D status. Each woman will be asked to ingest two pieces of toast onto which a dose of 35 μg of \[6,19,19-d3\]-vitamin D3 has been added. Women will return to the at 4 hour, 8 hour, Day 2, 10, 25, and 40 (± 2 days) for an additional blood sample (15 mL each) to assess the disappearance of the tri-deuterated D3, conversion into 25(OH)D3, and serum half-life of 25(OH)D3.

  Across 40 days study period

• Impact of obesity on vitamin D absorption

  A baseline blood sample (20 mL) will be obtained for analysis of the baseline concentrations of indicators of vitamin D status. Each woman will be asked to ingest two pieces of toast onto which a dose of 35 μg of \[6,19,19-d3\]-vitamin D3 has been added. Women will return to the at 4 hour, 8 hour, Day 2, 10, 25, and 40 (± 2 days) for an additional blood sample (15 mL each) to assess the disappearance of the tri-deuterated D3, conversion into 25(OH)D3, and serum half-life of 25(OH)D3. Body composition measure using Bioelectrical Impedance Analysis (BIA) will be conducted on Day 0 for all participants and Day 40 for he pregnant participants to obtain information on BMI and fat mass. Adipose tissue (\<1 gram) will be extracted using needle biopsy from the upper buttock area on all participants for D content analysis.

  Across 40 days study period

• Impact of ancestry on serum vitamin D absorption

  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 35 ug of \[6,19,19-d3\]-vitamin D3 has been added. Women will return to the at 4 hour, 8 hour, Day 1, 3, 10, 25, and 40 (± 2 days) for an additional blood sample (15 mL each) to assess the disappearance of the tri-deuterated D3, conversion into 25(OH)D3, and serum half-life of 25(OH)D3. DNA will be extracted to perform ancestry genotyping and determine vitamin D binding protein genotypes.

  Across 40 days study period

Secondary Outcomes (1)

• Placental protein quantification

  Across 40 days study period

Study Arms (2)

Vitamin D dynamics- pregnant

Pregnant women recruited to measure Vitamin D dynamics during pregnancy.

Other: Vitamin D dynamics-pregnant

Vitamin D dynamics-nonpregnant

Non-pregnant women recruited to measure Vitamin D dynamics.

Other: Vitamin D dynamics-nonpregnant

Interventions

Vitamin D dynamics-nonpregnant OTHER

tracer dose of deuterated vitamin D3

Vitamin D dynamics-nonpregnant

Vitamin D dynamics-pregnant OTHER

tracer dose of deuterated vitamin D3

Vitamin D dynamics- pregnant

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women and non-pregnant women of reproductive age

You may qualify if:

• Self-reported White and Black women
• Age 20-39
• Body mass index (BMI) 1or pre-pregnancy BMI (If currently pregnant) either 18.5-24.9 kg/m2 or greater than or equal to 30 kg/m2
• Singleton pregnancy
• Recruited in first trimester, second trimester, or third trimester
• No pregnancy complications

You may not qualify if:

• BMI or pre-pregnancy BMI \<18.5 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)
• Gestational diabetes
• Pregnancy hypertension

Sponsors & Collaborators

• Cornell University: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester, 518 Hylan Building

Rochester, New York, 14627, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples and extracted DNA sample (biospecimen retention will be both with and without DNA)

Study Officials

• Kimberly O. O'Brien, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Eva Pressman, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly O. O'Brien, PhD

CONTACT

607-255-3743; koo4@cornell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 10, 2016
• Study Start: October 28, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)