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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD043921 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cholecalciferol-400 IU | Active Comparator | Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day |
|
| cholecalciferol 2000 IU | Experimental | Experimental group receiving 2000 IU total vitamin D3/day. |
|
| cholecalciferol 4000 IU | Experimental | Experimental group receiving 4000 IU/day cholecalciferol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol (vitamin D3) | Drug | randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 25-Hydroxyvitamin D Concentration | Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce W. Hollis, Ph.D. | Medical University of South Carolina | Principal Investigator |
| Carol L. Wagner, M.D. | Medical University of South Carolina | Principal Investigator |
| Donna Johnson, M.D. | Medical University of South Carolina | Study Director |
| Thomas C. Hulsey, Sc.D. | Medical University of South Carolina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15671234 | Background | 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. | |
| 15689596 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cholecalciferol-400 IU | Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
| FG001 | Cholecalciferol 2000 IU | Experimental group receiving 2000 IU total vitamin D3/day. cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
| FG002 | Cholecalciferol 4000 IU | Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cholecalciferol-400 IU | Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 25-Hydroxyvitamin D Concentration | Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery | Posted | Mean | Standard Deviation | ng/mL | 7 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cholecalciferol-400 IU | Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy loss (miscarriage/fetal death) | Pregnancy, puerperium and perinatal conditions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complications of Pregnancy | Pregnancy, puerperium and perinatal conditions | Examples include preterm birth or labor complications due to infection, pre-eclampsia, gestational diabetes, etc. (not reported separately due to small numbers) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carol Wagner | Medical University of South Carolina | 18437922112 | wagnercl@musc.edu |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| cholecalciferol | Drug | comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
|
|
| 21706518 | Result | 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. |
| 21857221 | Result | 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. |
| 39077939 | Derived | Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5. |
| 37918363 | Derived | Reed SG, Fan S, Wagner CL, Lawson AB. Predictors of Developmental Defects of Enamel in Primary Maxillary Central Incisors Using Bayesian Model Selection. Caries Res. 2024;58(1):30-38. doi: 10.1159/000534793. Epub 2023 Nov 2. |
| 29046301 | Derived | 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. |
| Cholecalciferol 2000 IU |
Experimental group receiving 2000 IU total vitamin D3/day. cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
| BG002 | Cholecalciferol 4000 IU | Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Cholecalciferol 4000 IU | Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy |
|
|
| 9 |
| 166 |
| 22 |
| 166 |
| EG001 | Cholecalciferol 2000 IU | Experimental group receiving 2000 IU total vitamin D3/day. cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy | 4 | 167 | 35 | 167 |
| EG002 | Cholecalciferol 4000 IU | Experimental group receiving 4000 IU/day cholecalciferol cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy | 13 | 168 | 27 | 168 |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |