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Sponsors and Collaborators: |
Medical University of South Carolina National Institutes of Health (NIH) |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00292591 |
The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race.
Condition | Intervention | Phase |
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Vitamin D Deficiency |
Drug: cholecalciferol (vitamin D3) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Vitamin D Requirements During Pregnancy |
Estimated Enrollment: | 540 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | December 2008 |
The prevalence of hypovitaminosis D in reproductive aged African-American women occurs at a rate of > 40%. Two factors have contributed to this public health problem: an inadequate DRI for vitamin D and avoidance of sun exposure/use of sunscreen. This startling rate of hypovitaminosis D requires that the DRI for vitamin D in pregnancy be evaluated in a detailed manner. The Cochrane Library (2002) released a report stating that there is insufficient data to evaluate the effects of vitamin D supplementation during pregnancy. Recently, the safety of prolonged supplementation with up to 25x's DRI (10,000 IU/day) was demonstrated in nonpregnant adults. It is essential to determine what dose of vitamin D is required to eliminate hypovitaminosis D during pregnancy and provide the fetus/neonate with adequate vitamin D stores during development and growth, particularly in darkly pigmented individuals. The aim of this research proposal, then, is to determine the efficacy, effectiveness, and safety of maternal vitamin D supplementation (as a function of ethnicity and UV exposure) in the prevention of hypovitaminosis D in the pregnant mother and her fetus/neonate. We hypothesize that darkly pigmented mothers will require substantially higher oral supplementation with vitamin D to eliminate hypovitaminosis D as compared to their Caucasian counterparts. We propose a comprehensive clinical trial to test our hypothesis. Mothers at 12 weeks' gestation will be randomized to one of three vitamin D treatment groups:
Calcium and vitamin D homeostasis and skeletal remodeling in the mother will be monitored closely throughout the pregnancy. Bone density of the mother will be measured at 12 weeks’ gestation and one-month postpartum. Follow-up growth and skeletal integrity assessments of the infant will be performed at birth, 1, 6 and 12 months stratified by infant feeding regime. Through these proposed studies, the prevalence of hypovitaminosis D among mothers, their developing fetuses and neonates, and the utility of maternal therapeutic intervention with vitamin D for both mother and fetus/infant will be assessed.
Ages Eligible for Study: | 16 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carol L. Wagner, M.D. | (843) 792-8829 | wagnercl@musc.edu |
Contact: Donna Johnson, M.D. | (843) 876-1272 | johnsodo@musc.edu |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Principal Investigator: Bruce W. Hollis, Ph.D. | |
Principal Investigator: Carol L. Wagner, M.D. | |
Sub-Investigator: Donna Johnson, M.D. |
Principal Investigator: | Bruce W. Hollis, Ph.D. | Medical University of South Carolina |
Principal Investigator: | Carol L. Wagner, M.D. | Medical University of South Carolina |
Study Director: | Donna Johnson, M.D. | Medical University of South Carolina |
Study Chair: | Thomas C. Hulsey, Sc.D. | Medical University of South Carolina |
Study ID Numbers: | R01 HD043921, MUSC HR#10727 |
Study First Received: | February 15, 2006 |
Last Updated: | June 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00292591 History of Changes |
Health Authority: | United States: Food and Drug Administration |
vitamin D cholecalciferol pregnancy bone mineral density pregnancy |
Vitamin D Deficiency Cholecalciferol Vitamin D Malnutrition Avitaminosis Vitamins |
Nutrition Disorders Bone Density Conservation Agents Trace Elements Micronutrients Deficiency Diseases |
Vitamin D Deficiency Cholecalciferol Avitaminosis Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |
Malnutrition Vitamin D Vitamins Nutrition Disorders Micronutrients Deficiency Diseases |