Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation

Study Description

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Brief Summary:

The purpose of this study is to give all mothers the best chance for a healthy pregnancy through vitamin D supplementation. We will study women of diverse racial/ethnic backgrounds who will receive either the current vitamin D standard of 400 IU/day (in the prenatal vitamin) or 4000 IU/day (dose found in previous pregnancy studies to achieve vitamin D sufficiency).

This research is sponsored by the W.K. Kellogg Foundation and the Medical University of South Carolina. The purpose of this study is to examine the effectiveness and infection-fighting properties of the body in relationship to vitamin D levels. This study is being done at the Medical University of South Carolina (MUSC) clinics, and will involve approximately 450 volunteers.

Condition or disease	Intervention/treatment	Phase
Vitamin D Status During Pregnancy.	Drug: Vitamin D3 4000 IU in gummy form; Drug: Placebo gummy vitamin	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	410 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation
Study Start Date :	January 2013
Estimated Primary Completion Date :	April 2017
Estimated Study Completion Date :	April 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Vitamin D 4000 IU; Subjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.	Drug: Vitamin D3 4000 IU in gummy form; Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy.
Placebo Comparator: placebo gummy vitamin; Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)	Drug: Placebo gummy vitamin; Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy.

Outcome Measures

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Primary Outcome Measures :

1. Maternal and neonatal health status as a function of maternal and infant vitamin D status [ Time Frame: These visits will include the initial recruitment of mother at 10-14 weeks of pregnancy, monthly study visits, delivery study visit. Nine months total. ]
   Because the primary endpoint of the study is change in 25(OH)D from baseline to delivery, the primary analysis will be restricted to participants who have remained in the study until delivery and provided a blood sample within 6 weeks prior to delivery, at delivery, or at the post-delivery visit (completers-only analysis).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Any mother (18-45 years of age) who presents to her obstetrician or midwife at the Medical University of SC (MUSC), Charleston, SC obstetrical facilities within the first 14 weeks after her last menstrual period (LMP) with confirmation of a singleton pregnancy will be eligible for enrollment in the study. Mothers of diverse ethnic backgrounds (African-American, Asian, Caucasian and Hispanic) will be actively recruited.

Exclusion Criteria:

• Mothers with pre-existing calcium, uncontrolled thyroid disease, parathyroid conditions, or who require chronic diuretic or cardiac medication therapy including calcium channel blockers will not be eligible for enrollment into the study. Mothers with pre-existing sickle cell disease (not trait only), sarcoidosis, Crohn's disease, or ulcerative colitis may not participate in the study. In addition, because of the potentially confounding effect of multiple fetuses, mothers with multiple gestations will not be eligible for participation in the study. A sub-group of approximately 100 subjects with known diabetes, hypertension, HIV, or morbid obesity (body mass index > 49) will participate in the study.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

W.K. Kellogg Foundation

Investigators

Principal Investigator:	Carol L Wagner, MD	Medical University of South Carolina

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Hamilton SA, McNeil R, Hollis BW, Davis DJ, Winkler J, Cook C, Warner G, Bivens B, McShane P, Wagner CL. Profound Vitamin D Deficiency in a Diverse Group of Women during Pregnancy Living in a Sun-Rich Environment at Latitude 32°N. Int J Endocrinol. 2010;2010:917428. doi: 10.1155/2010/917428. Epub 2010 Dec 9.

Johnson DD, Wagner CL, Hulsey TC, McNeil RB, Ebeling M, Hollis BW. Vitamin D deficiency and insufficiency is common during pregnancy. Am J Perinatol. 2011 Jan;28(1):7-12. doi: 10.1055/s-0030-1262505. Epub 2010 Jul 16.

Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. Erratum in: J Bone Miner Res. 2011 Dec; 26(12):3001.

Hollis BW, Wagner CL. Vitamin D and pregnancy: skeletal effects, nonskeletal effects, and birth outcomes. Calcif Tissue Int. 2013 Feb;92(2):128-39. doi: 10.1007/s00223-012-9607-4. Epub 2012 May 24. Review.

Wagner CL, McNeil R, Hamilton SA, Winkler J, Rodriguez Cook C, Warner G, Bivens B, Davis DJ, Smith PG, Murphy M, Shary JR, Hollis BW. A randomized trial of vitamin D supplementation in 2 community health center networks in South Carolina. Am J Obstet Gynecol. 2013 Feb;208(2):137.e1-13. doi: 10.1016/j.ajog.2012.10.888. Epub 2012 Nov 3.

Wagner C, McNeil R, Ebeling M, Hulsey T, Johnson D, Hollis B. Analysis of Two Randomized Vitamin D3 Supplementation Trials during Pregnancy: Health Characteristics and Outcomes. Pediatr Res. 2012;#750466 (abstract).

Responsible Party:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT01932788 History of Changes
Other Study ID Numbers:	20570
First Posted:	August 30, 2013
Last Update Posted:	April 11, 2016
Last Verified:	January 2016

Keywords provided by Medical University of South Carolina:

pregnancy; Vitamin D status

Additional relevant MeSH terms:

Vitamins; Vitamin D; Ergocalciferols; Cholecalciferol	Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents