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NCT00412087 · ClinicalTrials.gov registry record · Phase 3
Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina
A Phase 3 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 3
- Development phase
- 564
- Enrollment target
NCT00412087 is a Phase 3 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 564 participants.
The verdict
NCT00412087, a Phase 3 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 564 participants
- Enrollment target
Study 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 p
Interventions
- DRUG cholecalciferol (vitamin D3)
- DRUG cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 564 participants |
| Start Date | 2007-01 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00412087
The ClinicalTrials.gov registry entry for NCT00412087 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 564 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which cholecalciferol (vitamin D3) is the first listed.
NCT00412087 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00412087 about?
NCT00412087 is a clinical study titled "Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina". 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 de...
What is the current status of trial NCT00412087?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 564 participants. The study started on 2007-01. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00412087?
The interventions under investigation include: cholecalciferol (vitamin D3) (DRUG), cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT00412087?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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