Vitamin D DeficiencyPhase 3NCT00292591
Evaluation of Vitamin D Requirements During Pregnancy
A Phase 3 study testing cholecalciferol (vitamin D3) and cholecalciferol in people with Vitamin D Deficiency, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol (vitamin D3) and cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women who are within the ages of 16-45 years
- In good general health
- Less than 12 weeks pregnant (based on last menstrual period)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol (vitamin D3), cholecalciferol
- Keywords
- vitamin D, cholecalciferol, pregnancy, bone mineral density
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol (vitamin D3)Drug
randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day
cholecalciferolDrug
Also called vitamin D3
comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy
| Study group | Role | What they receive |
|---|---|---|
| cholecalciferol-400 IU | Active comparator | Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day Receives: Drug: cholecalciferol (vitamin D3); Drug: cholecalciferol |
| cholecalciferol 2000 IU | Experimental | Experimental group receiving 2000 IU total vitamin D3/day. Receives: Drug: cholecalciferol (vitamin D3); Drug: cholecalciferol |
| cholecalciferol 4000 IU | Experimental | Experimental group receiving 4000 IU/day cholecalciferol Receives: Drug: cholecalciferol (vitamin D3); Drug: cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-Hydroxyvitamin D Concentration
Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJan 2004
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Carol Wagner, Medical University of South Carolina
- Investigators
- Bruce W. Hollis, Ph.D., Principal investigator, Medical University of South CarolinaCarol L. Wagner, M.D., Principal investigator, Medical University of South CarolinaDonna Johnson, M.D., Study director, Medical University of South CarolinaThomas C. Hulsey, Sc.D., Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292591
- Sponsor's protocol ID
- R01HD043921
- Other IDs
- 5R01HD043921
- Status last verified
- Aug 2016
- First submitted
- 15 Feb 2006
- Last updated
- 19 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 15671234Hollis 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.
PubMed 15689596Hollis 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.
PubMed 21706518Hollis 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.
PubMed 21857221Palacios 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.
PubMed 39077939Reed 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.
PubMed 37918363Wei 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.
PubMed 29046301
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vitamin D Requirements During Pregnancy
- ClinicalTrials.gov ID
- NCT00292591
- Acronym / sponsor ID
- R01HD043921
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, cholecalciferol, pregnancy, bone mineral density
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2004
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 16 Feb 2006 (estimated)
- Results
- Posted 9 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cholecalciferol-400 IU | Active comparator | Drug: cholecalciferol (vitamin D3), Drug: cholecalciferolControl group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day |
| cholecalciferol 2000 IU | Experimental | Drug: cholecalciferol (vitamin D3), Drug: cholecalciferolExperimental group receiving 2000 IU total vitamin D3/day. |
| cholecalciferol 4000 IU | Experimental | Drug: cholecalciferol (vitamin D3), Drug: cholecalciferolExperimental group receiving 4000 IU/day cholecalciferol |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women who are within the ages of 16-45 years
- In good general health
- Less than 12 weeks pregnant (based on last menstrual period)
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferol (vitamin D3)randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day | Drug | cholecalciferol 2000 IU, cholecalciferol 4000 IU, cholecalciferol-400 IU |
| cholecalciferolAlso: vitamin D3comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy | Drug | cholecalciferol 2000 IU, cholecalciferol 4000 IU, cholecalciferol-400 IU |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15671234Hollis 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.
- Background: PubMed 15689596Hollis 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.
- Results publication: PubMed 21706518Hollis 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.
- Results publication: PubMed 21857221Hollis 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.
- Derived from this study: PubMed 39077939Palacios 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.
- Derived from this study: PubMed 37918363Reed 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.
- Derived from this study: PubMed 29046301Wei 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce W. Hollis, Ph.D. principal investigator
Medical University of South Carolina
Carol L. Wagner, M.D. principal investigator
Medical University of South Carolina
Donna Johnson, M.D. study director
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cholecalciferol (vitamin D3) and cholecalciferol in people with Vitamin D Deficiency, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25-Hydroxyvitamin D Concentration (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00292591, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.