Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Medical University of South Carolina
Sponsor:
Collaborator:
W.K. Kellogg Foundation
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01932788
First received: August 27, 2013
Last updated: May 30, 2014
Last verified: May 2013
  Purpose

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 Intervention Phase
Vitamin D Status During Pregnancy.
Drug: Vitamin D3 4000 IU in gummy form
Drug: Placebo gummy vitamin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 450
Study Start Date: January 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932788

Contacts
Contact: Carol Wagner, MD 843-792-2401 wagnercl@musc.edu
Contact: Ashley Green 843-792-8454 greenan@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Carol L Wagner, MD    843-792-2401    wagnercl@musc.edu   
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

Publications:
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
Study First Received: August 27, 2013
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014