Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Vitamin D Requirements During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carol Wagner, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00292591
First received: February 15, 2006
Last updated: April 25, 2012
Last verified: April 2012

February 15, 2006
April 25, 2012
January 2004
January 2010   (final data collection date for primary outcome measure)
25(OH)D levels throughout pregnancy and following delivery and bone mineral density of both mother and infant [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
  • 25(OH)D levels throughout pregnancy and following delivery
  • bone mineral density of both mother and infant
Complete list of historical versions of study NCT00292591 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Vitamin D Requirements During Pregnancy
Evaluation of Vitamin D Requirements During Pregnancy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vitamin D Deficiency
  • Drug: cholecalciferol (vitamin D3)
    randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
  • Drug: cholecalciferol
    comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
    Other Name: vitamin D3
  • Active Comparator: cholecalciferol-400 IU
    Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
    Interventions:
    • Drug: cholecalciferol (vitamin D3)
    • Drug: cholecalciferol
  • Experimental: cholecalciferol 2000 IU
    Experimental group receiving 2000 IU total vitamin D3/day.
    Interventions:
    • Drug: cholecalciferol (vitamin D3)
    • Drug: cholecalciferol
  • Experimental: cholecalciferol 4000 IU
    Experimental group receiving 4000 IU/day cholecalciferol
    Interventions:
    • Drug: cholecalciferol (vitamin D3)
    • Drug: cholecalciferol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
516
January 2010
January 2010   (final data collection date for primary outcome measure)

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.)
Female
16 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00292591
R01 HD043921, 5R01HD043921
Not Provided
Carol Wagner, Medical University of South Carolina
Medical University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
Medical University of South Carolina
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP