Evaluation of Vitamin D Requirements During Pregnancy
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ClinicalTrials.gov Identifier: NCT00292591 |
Recruitment Status :
Completed
First Posted : February 16, 2006
Results First Posted : August 9, 2016
Last Update Posted : September 19, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vitamin D Deficiency | Drug: cholecalciferol (vitamin D3) Drug: cholecalciferol | Phase 3 |
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:
- Control, 400-,
- 2,000-, or
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 501 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of Vitamin D Requirements During Pregnancy |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |
Arm | Intervention/treatment |
---|---|
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 |
- 25-Hydroxyvitamin D Concentration [ Time Frame: 7 months ]Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery

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Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women who are within the ages of 16-45 years
- In good general health
- Less than 12 weeks pregnant (based on last menstrual period)
Exclusion Criteria:
- Mothers with preexisting type I or type II diabetes
- Mothers with preexisting hypertension
- Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
- Mothers with multiple fetuses (e.g., twins, triplets, etc.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292591
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
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 |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Carol Wagner, Professor of Pediatrics, Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00292591 |
Other Study ID Numbers: |
R01HD043921 ( U.S. NIH Grant/Contract ) 5R01HD043921 ( U.S. NIH Grant/Contract ) |
First Posted: | February 16, 2006 Key Record Dates |
Results First Posted: | August 9, 2016 |
Last Update Posted: | September 19, 2016 |
Last Verified: | August 2016 |
vitamin D cholecalciferol pregnancy bone mineral density |
Vitamin D Deficiency Vitamin D Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Ergocalciferols Cholecalciferol |
Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |