Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Medical University of South Carolina
Collaborator:
Thrasher Research Fund
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins