Vitamin D Dynamics in Women
ConditionPregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-39
SponsorCornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
BMI or pre-pregnancy BMI <18.5 kg/m2
Human immunodeficiency virus (HIV) infection
Diagnosed eating disorder
Malabsorption disease
Trial population
Pregnant women and non-pregnant women of reproductive age
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Vitamin D dynamics-pregnant
Other interventiontracer dose of deuterated vitamin D3
Vitamin D dynamics-nonpregnant
Other interventiontracer dose of deuterated vitamin D3
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Vitamin D dynamics- pregnant1 intervention
Group B: Vitamin D dynamics-nonpregnant1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Across 40 days study period2
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.
Time frame
Across 40 days study period3
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.
Time frame
Across 40 days study periodSecondary outcomes
1
Placental protein quantification
At delivery placental tissue will be collected for evaluation of placental mRNA expression and protein abundance of CYP2R1, CYP24A1 and CYP27B1 following methods we, and others have published. This will help us obtain data on placental contributions to D utilization to inform our mathematical model and hypotheses.
Time frame
Across 40 days study periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cornell University
Lead sponsor
University of Rochester
Collaborator
Source ClinicalTrials.gov