Evaluation of Vitamin D Requirements During Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: cholecalciferol-400 IU
Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
|
randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
Other Names:
|
|
Experimental: cholecalciferol 2000 IU
Experimental group receiving 2000 IU total vitamin D3/day.
|
randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
Other Names:
|
|
Experimental: cholecalciferol 4000 IU
Experimental group receiving 4000 IU/day cholecalciferol
|
randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
7 months
|
Collaborators and Investigators
Collaborators
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
Publications and helpful links
General Publications
- Hollis BW. Circulating 25-hydroxyvitamin D levels indicative of vitamin D sufficiency: implications for establishing a new effective dietary intake recommendation for vitamin D. J Nutr. 2005 Feb;135(2):317-22. doi: 10.1093/jn/135.2.317.
- Hollis BW, Wagner CL. Normal serum vitamin D levels. N Engl J Med. 2005 Feb 3;352(5):515-6; author reply 515-6. doi: 10.1056/NEJM200502033520521. No abstract available.
- Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. Erratum In: J Bone Miner Res. 2011 Dec; 26(12):3001.
- Hollis BW, Wagner CL. Vitamin D requirements and supplementation during pregnancy. Curr Opin Endocrinol Diabetes Obes. 2011 Dec;18(6):371-5. doi: 10.1097/MED.0b013e32834b0040.
- Wei W, Shary JR, Garrett-Mayer E, Anderson B, Forestieri NE, Hollis BW, Wagner CL. Bone mineral density during pregnancy in women participating in a randomized controlled trial of vitamin D supplementation. Am J Clin Nutr. 2017 Dec;106(6):1422-1430. doi: 10.3945/ajcn.116.140459. Epub 2017 Oct 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD043921 (U.S. NIH Grant/Contract)
- 5R01HD043921 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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