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Evaluation of Vitamin D Requirements During Pregnancy
This study is currently recruiting participants.
Verified by Medical University of South Carolina, January 2007
First Received: February 15, 2006   Last Updated: June 20, 2007   History of Changes
Sponsors and Collaborators: Medical University of South Carolina
National Institutes of Health (NIH)
Information provided by: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00292591
  Purpose

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
Vitamin D Deficiency
Drug: cholecalciferol (vitamin D3)
Phase III

MedlinePlus related topics: Minerals
Drug Information available for: Cholecalciferol Vitamin D
U.S. FDA Resources
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

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 25(OH)D levels throughout pregnancy and following delivery
  • bone mineral density of both mother and infant

Estimated Enrollment: 540
Study Start Date: January 2004
Estimated Study Completion Date: December 2008
Detailed Description:

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:

  1. Control, 400-,
  2. 2,000-, or
  3. 4,000 IU/day to be continued throughout pregnancy.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women who are within the ages of 16-45 years
  2. In good general health
  3. Less than 12 weeks pregnant (based on last menstrual period)

Exclusion Criteria:

  1. Mothers with preexisting type I or type II diabetes
  2. Mothers with preexisting hypertension
  3. Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
  4. Mothers with multiple fetuses (e.g., twins, triplets, etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292591

Contacts
Contact: Carol L. Wagner, M.D. (843) 792-8829 wagnercl@musc.edu
Contact: Donna Johnson, M.D. (843) 876-1272 johnsodo@musc.edu

Locations
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.            
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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
  More Information

Publications:
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

Keywords provided by Medical University of South Carolina:
vitamin D
cholecalciferol
pregnancy
bone mineral density
pregnancy

Study placed in the following topic categories:
Vitamin D Deficiency
Cholecalciferol
Vitamin D
Malnutrition
Avitaminosis
Vitamins
Nutrition Disorders
Bone Density Conservation Agents
Trace Elements
Micronutrients
Deficiency Diseases

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009