Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina
Condition: Vitamin D Deficiency; Pregnancy
MeSH terms: Vitamin D Deficiency
Intervention: cholecalciferol (vitamin D3); cholecalciferol; cholecalciferol
Intervention description: randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day; randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3; cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.
Intervention MeSH terms: Vitamin D; Ergocalciferols; 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: 564.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin D; cholecalciferol; pregnant women

Summary:

      Science News (October 2004) called vitamin D deficiency a "silent epidemic" in America, with
      no group unaffected. Using new guidelines of optimal vitamin D levels, more than 90% of
      African American women now suffer from vitamin D deficiency. Deficiency during pregnancy has
      profound effects on the developing fetus. Other systems besides bones are affected by vitamin
      D deficiency, including an increased risk of autoimmune diseases such as rheumatoid
      arthritis, multiple sclerosis, type I diabetes, and certain cancers.

      This study proposes to examine and manage vitamin D levels in more than one thousand women in
      an underserved population in South Carolina. The women will be from the patient population
      seeking OB/GYN and Pediatric services through Eau Claire Cooperative Health Centers, Inc.
      (ECCHC), a network of ten clinics in three counties in the center of the state approximately
      70 miles from Charleston, SC. ECCHC is one of approximately 1000 community health centers
      supported through Health and Human Services' (HHS) Health Resources and Services
      Administration's (HRSA), Bureau of Primary Health Care.

      The research objectives for this project will be managed through the Pediatric Nutritional
      Sciences Research Center of the Children's Research Institute at the Medical University of
      South Carolina, Charleston, SC, in collaboration with ECCHC. The research aims will evaluate
      vitamin D levels and possible contributing factors to the levels in pregnant women. Women who
      present to ECCHC within the first trimester of pregnancy will be randomized to one of two
      doses of vitamin D supplementation shown to be effective in other groups. Each pregnant
      mother will begin supplementation during the 12th week of pregnancy and will be followed
      closely throughout pregnancy for one year to determine the effectiveness of supplementation
      on vitamin D status, overall health of mother, and of her infant following delivery.

      We expect to observe severe vitamin D deficiency in a considerable percentage of the mothers
      and their infants who receive care at ECCHC, especially those individuals with darker
      pigmentation. When the extent of vitamin D deficiency within each racial/ethnic group is
      better defined and their supplementation requirements identified, we will be better able to
      establish guidelines for supplementation and health maintenance, and set policy
      recommendations for the dietary recommended intake of vitamin D. Those women and their
      infants identified as deficient in vitamin D will be important in establishing community
      health care policies for vitamin D surveillance and supplementation strategies. The results
      will allow us to implement specific dietary and/or medical interventions aimed at correcting
      hypovitaminosis D in the population in this study and other similar populations being served
      by the more than 1000 community health centers nationally.
    

Eligibility criteria:

        Inclusion Criteria:

        Aim 1: Any mother who presents to her obstetrician or midwife at Eau Claire with
        confirmation of a singleton pregnancy will be eligible for enrollment in Aim 1.

        Aim 2: If the mother also is <12 completed weeks of gestation, she will be eligible for
        participation of Aim 2 of the study. Mothers of diverse ethnic background
        (African-American, Asian, Caucasian, Asian and Hispanic) actively will be recruited. There
        are no age exclusion criteria.

        Exclusion Criteria:

        Aim 1: There are no exclusion criteria.

        Aim 2: Mothers with pre-existing calcium, 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 active thyroid disease (e.g., Graves,
        Hashimoto's or thyroiditis) will not be eligible to participate in the study; however,
        mothers on thyroid supplement with normal serological parameters may participate in the
        study if they are without any other endocrine dysfunction. Mothers with diabetes will not
        be excluded from participation in the study as vitamin D deficiency appears linked with
        insulin resistance and may aggravate the maternal condition.