Evaluation of Vitamin D Requirements During Pregnancy
2 other identifiers
interventional
501
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2004
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 15, 2006
CompletedFirst Posted
Study publicly available on registry
February 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
August 9, 2016
CompletedSeptember 19, 2016
August 1, 2016
6 years
February 15, 2006
June 28, 2016
August 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
25-Hydroxyvitamin D Concentration
Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery
7 months
Study Arms (3)
cholecalciferol-400 IU
ACTIVE COMPARATORControl group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day
cholecalciferol 2000 IU
EXPERIMENTALExperimental group receiving 2000 IU total vitamin D3/day.
cholecalciferol 4000 IU
EXPERIMENTALExperimental group receiving 4000 IU/day cholecalciferol
Interventions
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
Eligibility Criteria
You may qualify if:
- Women who are within the ages of 16-45 years
- In good general health
- Less than 12 weeks pregnant (based on last menstrual period)
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (6)
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.
PMID: 15671234BACKGROUNDHollis 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.
PMID: 15689596BACKGROUNDHollis 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.
PMID: 21706518RESULTHollis 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.
PMID: 21857221RESULTPalacios 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.
PMID: 39077939DERIVEDWei 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.
PMID: 29046301DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carol Wagner
- Organization
- Medical University of South Carolina
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 15, 2006
First Posted
February 16, 2006
Study Start
January 1, 2004
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
September 19, 2016
Results First Posted
August 9, 2016
Record last verified: 2016-08