Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation
Condition: Vitamin D3 Deficiency
Intervention: Vitamin D3 4000 IU in gummy form; Placebo gummy vitamin
Intervention description: 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.; 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.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 342.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pregnancy; Vitamin D status

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.
    

Eligibility 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.