Status:
COMPLETED
Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Vitamin D Deficiency
Pregnancy
Eligibility:
FEMALE
16-45 years
Phase:
PHASE3
Brief 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 wo...
Detailed Description
With avoidance of sunlight exposure due to lifestyle changes and concerns regarding skin cancer and the resultant widespread use of sunscreen, very few Americans are meeting their needs for vitamin D ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT00412087
Start Date
January 1 2007
End Date
July 1 2009
Last Update
July 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eau Claire Cooperative Health Centers, Inc.
Columbia, South Carolina, United States, 29203