Vitamin D Status and Metabolism in Human Pregnancy

NCT03051867 | Completed

• 1 other identifier: OSP 74161
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to understand the effect of pregnancy on vitamin D metabolism and requirements as well as the modulatory role of the placenta in vitamin D metabolism during pregnancy. In addition, a human placental cell culture model will be employed to examine vitamin D metabolic flux in human trophoblast cells. The impact of maternal vitamin D status on maternal and fetal bone health during gestation will also be examined.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (7)

• Maternal circulating concentrations of 25-hydroxyvitamin D

  Serum 25-hydroxyvitamin D \[25(OH)D\] will be measured using an isotope dilution LC-MS/MS methodology, and the effect of reproductive state on serum 25(OH)D will be examined using a linear mixed model which considers confounding factors.

  Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)

• Maternal circulating concentrations of 1,25-dihydroxyvitamin D

  Plasma 1,25-dihydroxyvitamin D \[1,25(OH)2D\] will be measured using an EIA kit, and the effect of reproductive state on circulating 1,25(OH)2D will be examined using a linear mixed model which considers confounding factors.

  Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)

• Maternal circulating concentrations 24,25-dihydroxyvitamin D

  Plasma 24,25-dihydroxyvitamin D \[24,25(OH)2D\] will be measured using an isotope dilution LC-MS/MS methodology, and the effect of reproductive state on circulating 24,25(OH)2D will be examined using a linear mixed model which considers potential confounders.

  Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)

• Placental mRNA abundance of 25-hydroxylase

  Placental mRNA abundance of 25-hydroxylase \[CYP2R1\] will be measured using a qPCR, and the associations of placental CYP2R1 mRNA abundance with serum 25(OH)D will be examined using a linear mixed model which considers potential confounders.

  Delivery

• Placental mRNA abundance of 24-hydroxylase

  Placental mRNA abundance of 24-hydroxylase \[CYP24A1\] will be measured using a qPCR, and the associations of placental CYP24A1 mRNA abundance with circulating 24,25(OH)2D will be examined using a linear mixed model which considers potential confounders.

  Delivery

• Placental 25-hydroxyvitamin D

  25(OH)D will be measured from placental tissue using an isotope dilution LC-MS/MS methodology, and the associations of placental 25(OH)D with serum 25(OH)D as well as placental CYP2R1 mRNA abundance will be examined using a Pearson correlation test and a linear mixed model which considers potential confounders.

  Delivery

• Placental 24,25-dihydroxyvitamin D

  24,25(OH)2D will be measured from placental tissue using an isotope dilution LC-MS/MS methodology, and the associations of placental 24,25(OH)2D with circulating 25(OH)D and 24,25(OH)2D as well as placental CYP24A1 mRNA abundance will be examined using a Pearson correlation test and a linear mixed model which adjusts for potential confounders.

  Delivery

Secondary Outcomes (4)

• Maternal circulating intact parathyroid hormone

  Baseline (week 0; 26-29 wk gestation) and study-end (week 10; 36-39 wk gestation)

• Maternal circulating carboxy-terminal cross-linking telopeptide of type 1 collagen

  Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery

• Maternal urinary deoxypyridinoline/creatinine

  Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation)

• Maternal circulating osteocalcin

  Baseline (week 0; 26-29 wk gestation), study-end (week 10; 36-39 wk gestation), and delivery

Study Arms (2)

Third-trimester pregnant women

Women differing in their reproductive state (pregnant versus nonpregnant) will consume equivalent dietary intakes of vitamin D and related nutrients as part of a feeding study.

Nonpregnant control women

Women differing in their reproductive state (pregnant versus nonpregnant) will consume equivalent dietary intakes of vitamin D and related nutrients as part of a feeding study.

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of all healthy third-trimester pregnant (n=26) and nonpregnant (n=21) women who participated in the original RCT study.

You may qualify if:

• Age of 21-40 y
• Healthiness as assessed by health-related questionnaire, a blood chemistry profile, and a complete blood count
• Normal liver and kidney function
• Willingness to comply with the study protocol
• Singleton pregnancy (pregnant women only)

You may not qualify if:

• Use of tobacco, drug, or alcohol
• Use of prescription medications known to affect liver function
• Pregnancy associated complications

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

Location

Related Publications (9)

• Wagner CL, Taylor SN, Johnson DD, Hollis BW. The role of vitamin D in pregnancy and lactation: emerging concepts. Womens Health (Lond). 2012 May;8(3):323-40. doi: 10.2217/whe.12.17.

  PMID: 22554179 BACKGROUND

• Aghajafari F, Nagulesapillai T, Ronksley PE, Tough SC, O'Beirne M, Rabi DM. Association between maternal serum 25-hydroxyvitamin D level and pregnancy and neonatal outcomes: systematic review and meta-analysis of observational studies. BMJ. 2013 Mar 26;346:f1169. doi: 10.1136/bmj.f1169.

  PMID: 23533188 BACKGROUND

• Ma R, Gu Y, Zhao S, Sun J, Groome LJ, Wang Y. Expressions of vitamin D metabolic components VDBP, CYP2R1, CYP27B1, CYP24A1, and VDR in placentas from normal and preeclamptic pregnancies. Am J Physiol Endocrinol Metab. 2012 Oct 1;303(7):E928-35. doi: 10.1152/ajpendo.00279.2012. Epub 2012 Aug 7.

  PMID: 22871339 BACKGROUND

• Liu NQ, Hewison M. Vitamin D, the placenta and pregnancy. Arch Biochem Biophys. 2012 Jul 1;523(1):37-47. doi: 10.1016/j.abb.2011.11.018. Epub 2011 Dec 2.

  PMID: 22155151 BACKGROUND

• Olausson H, Goldberg GR, Laskey MA, Schoenmakers I, Jarjou LM, Prentice A. Calcium economy in human pregnancy and lactation. Nutr Res Rev. 2012 Jun;25(1):40-67. doi: 10.1017/S0954422411000187.

  PMID: 22894942 BACKGROUND

• Kalra P, Das V, Agarwal A, Kumar M, Ramesh V, Bhatia E, Gupta S, Singh S, Saxena P, Bhatia V. Effect of vitamin D supplementation during pregnancy on neonatal mineral homeostasis and anthropometry of the newborn and infant. Br J Nutr. 2012 Sep 28;108(6):1052-8. doi: 10.1017/S0007114511006246. Epub 2012 Jan 3.

  PMID: 22212646 BACKGROUND

• Hashemipour S, Lalooha F, Zahir Mirdamadi S, Ziaee A, Dabaghi Ghaleh T. Effect of vitamin D administration in vitamin D-deficient pregnant women on maternal and neonatal serum calcium and vitamin D concentrations: a randomised clinical trial. Br J Nutr. 2013 Nov 14;110(9):1611-6. doi: 10.1017/S0007114513001244. Epub 2013 Apr 29.

  PMID: 23628132 BACKGROUND

• Yan J, Jiang X, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Stabler SP, Allen RH, Caudill MA. Maternal choline intake modulates maternal and fetal biomarkers of choline metabolism in humans. Am J Clin Nutr. 2012 May;95(5):1060-71. doi: 10.3945/ajcn.111.022772. Epub 2012 Mar 14.

  PMID: 22418088 BACKGROUND

• Park H, Wood MR, Malysheva OV, Jones S, Mehta S, Brannon PM, Caudill MA. Placental vitamin D metabolism and its associations with circulating vitamin D metabolites in pregnant women. Am J Clin Nutr. 2017 Dec;106(6):1439-1448. doi: 10.3945/ajcn.117.153429. Epub 2017 Oct 11.

  PMID: 29021285 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, cord blood, placental tissue

Study Officials

• Marie Caudill, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: January 15, 2009
• Primary Completion: December 18, 2010
• Study Completion: December 18, 2011
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)