Pregnancy Clinical Trial
Official title:
Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina: A Prevalence and Supplementation Model for Community Health Care Centers in the U.S.
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 1,000 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.
Status | Completed |
Enrollment | 559 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Eau Claire Cooperative Health Centers, Inc. | Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | Thrasher Research Fund |
United States,
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;2 — View Citation
Hollis BW, Wagner CL. Nutritional vitamin D status during pregnancy: reasons for concern. CMAJ. 2006 Apr 25;174(9):1287-90. — View Citation
Hollis BW, Wagner CL. Vitamin D deficiency during pregnancy: an ongoing epidemic. Am J Clin Nutr. 2006 Aug;84(2):273. — View Citation
Hollis BW, Wagner CL. Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1752S-8S. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 25-hydroxy-vitamin D | 9 months | Yes | |
Secondary | parathyroid hormone | 9 months | Yes |
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