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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
  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)
Drug: cholecalciferol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Vitamin D Requirements During Pregnancy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 516
Study Start Date: January 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cholecalciferol-400 IU
Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
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
Experimental: cholecalciferol 2000 IU
Experimental group receiving 2000 IU total vitamin D3/day.
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
Experimental: cholecalciferol 4000 IU
Experimental group receiving 4000 IU/day cholecalciferol
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292591

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
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:
Responsible Party: Carol Wagner, Professor of Pediatrics, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00292591     History of Changes
Other Study ID Numbers: R01 HD043921, 5R01HD043921
Study First Received: February 15, 2006
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014