Vitamin D DeficiencyNCT01696409
The Effect Of Vitamin D On Measures Of Bone Health And Gene Expression
An observational study of Vitamin D Deficiency, run by Boston University at 1 site in United States.
Trial summary
Vitamin D deficiency is now recognized as one of the most common vitamin deficiencies in adults in the United States. Vitamin D deficiency has been connected to many chronic health diseases. The goal of this innovative research is to identify how vitamin D is able to have such wide ranging health benefits. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- 400 IU vitamin D3 and 2000 IU vitamin D3
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Students from Boston University Medical School
Who may be able to join
- Male and female adults of all races ages 18 years and older
Who cannot join
- 1. Pregnant and lactating women.
- 2. Current or recent history of hepatic or renal disease
- 3. History of taking a daily supplement that contains more than 400 IU vitamin D2 or vitamin D3 within the past month or taking a pharmacologic amount of vitamin D2 or one of the active vitamin D analogs including Zemplar (Paricalcitol), Dovonex (calcipotriol), Hectorol (vitamin D pro hormone)
- 4. Subjects who are taking antiseizure medications or glucocorticoids.
- 5. Exposure to a tanning bed or tanning on a beach for more than eight hours within the past month.
- 6. Known history of elevated calcium. (> 10.5 mg% (mg/dl))
- 7. History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat Malabsorption Syndrome, Crohn's Disease)
- 8. Unwilling to consent to this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin D on Measures of Bone Health and Gene Expression
Vitamin D deficiency is now recognized as one of the most common vitamin deficiencies in adults in the United States. Vitamin D deficiency has been connected to many chronic health diseases. The goal of this innovative research is to identify how vitamin D is able to have such wide ranging health benefits. This study will determine which genes are turned on and turned off in adults who receive 2000 IU vitamin D3 per day compared to 400 IU vitamin D3 per day. Results should provide important new insights about the health benefits of vitamin D for adults.
Read the detailed description
Vitamin D, commonly known as the sunshine vitamin, is produced in the skin from sun exposure as well as from dietary sources. However, very few foods naturally contain vitamin D and the amount of vitamin D in fortified foods typically, 100 IU per serving, has been totally inadequate in satisfying adults vitamin D requirement, which is now been estimated to be at least 2,000 IU of vitamin D a day. As a result, vitamin D deficiency is rapidly being recognized world-wide as the most common vitamin deficiency. Upwards of 50-100% of children and adults have been reported as being vitamin D deficient depending on ethnicity, latitude and skin pigmentation. The investigators reported in women at the time of delivery that 76% of mothers and 81% of newborns were vitamin D deficient despite the fact that the mother was taking a prenatal vitamin containing 400 IU vitamin D and drinking two glasses of milk a day. The investigators also reported 30-80% vitamin D deficiency rates in white and black children, healthy young, middle aged and older adults. There have been numerous epidemiologic and clinical observations relating vitamin D deficiency to many chronic diseases and there are many isolated but no comprehensive studies evaluating various genes that are either suppressed or enhanced by 1,25-dihydroxyvitamin D [1,25(OH)2D]. It has been estimated that upwards of 2000 genes are directly or indirectly influence by 1,25(OH)2 D. To date, however, there have not been any genomic signatures identified in humans in response to correction of vitamin D deficiency. The goal of this pilot study is to determine whether or not vitamin D3 supplementation will affect biomarkers for calcium and bone metabolism, and how they alter gene expression biomarkers, especially genes related to the non-skeletal actions of vitamin D.
- Conditions
- Vitamin D Deficiency
- Being tested
- 400 IU vitamin D3, 2000 IU vitamin D3
- 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.
400 IU vitamin D3Dietary supplement
Take 400 IU once/day for 2 months
2000 IU vitamin D3Dietary supplement
2000 IU vitamin D3 once/day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Arm A | 400 IU vitamin D3 once a day for 2 months Receives: Dietary Supplement: 400 IU vitamin D3 | |
| Arm B | 2000 IU Vitamin D3 once/day for 2 months Receives: Dietary Supplement: 2000 IU vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression
Measurement of mRNA levels from genes specific to bone, calcium, and non-skeletal functions.
Measured: Baseline and Final Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Boston UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael F. Holick, Boston University
- Investigators
- Michael F Holick, PhD, MD, Principal investigator, BUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696409
- Sponsor's protocol ID
- Vitamin D and Gene Expression
- Status last verified
- Apr 2017
- First submitted
- 25 Jun 2012
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hossein-nezhad A, Spira A, Holick MF. Influence of vitamin D status and vitamin D3 supplementation on genome wide expression of white blood cells: a randomized double-blind clinical trial. PLoS One. 2013;8(3):e58725. doi: 10.1371/journal.pone.0058725. Epub 2013 Mar 20.
PubMed 23527013
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D on Measures of Bone Health and Gene Expression
- ClinicalTrials.gov ID
- NCT01696409
- Acronym / sponsor ID
- Vitamin D and Gene Expression
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D deficiency is now recognized as one of the most common vitamin deficiencies in adults in the United States. Vitamin D deficiency has been connected to many chronic health diseases. The goal of this innovative research is to identify how vitamin D is able to have such wide ranging health benefits. This study will determine which genes are turned on and turned off in adults who receive 2000 IU vitamin D3 per day compared to 400 IU vitamin D3 per day. Results should provide important new insights about the health benefits of vitamin D for adults.
Detailed description
Vitamin D, commonly known as the sunshine vitamin, is produced in the skin from sun exposure as well as from dietary sources. However, very few foods naturally contain vitamin D and the amount of vitamin D in fortified foods typically, 100 IU per serving, has been totally inadequate in satisfying adults vitamin D requirement, which is now been estimated to be at least 2,000 IU of vitamin D a day. As a result, vitamin D deficiency is rapidly being recognized world-wide as the most common vitamin deficiency. Upwards of 50-100% of children and adults have been reported as being vitamin D deficient depending on ethnicity, latitude and skin pigmentation. The investigators reported in women at the time of delivery that 76% of mothers and 81% of newborns were vitamin D deficient despite the fact that the mother was taking a prenatal vitamin containing 400 IU vitamin D and drinking two glasses of milk a day. The investigators also reported 30-80% vitamin D deficiency rates in white and black children, healthy young, middle aged and older adults. There have been numerous epidemiologic and clinical observations relating vitamin D deficiency to many chronic diseases and there are many isolated but no comprehensive studies evaluating various genes that are either suppressed or enhanced by 1,25-dihydroxyvitamin D [1,25(OH)2D]. It has been estimated that upwards of 2000 genes are directly or indirectly influence by 1,25(OH)2 D. To date, however, there have not been any genomic signatures identified in humans in response to correction of vitamin D deficiency. The goal of this pilot study is to determine whether or not vitamin D3 supplementation will affect biomarkers for calcium and bone metabolism, and how they alter gene expression biomarkers, especially genes related to the non-skeletal actions of vitamin D.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Dietary Supplement: 400 IU vitamin D3400 IU vitamin D3 once a day for 2 months |
| Arm B | – | Dietary Supplement: 2000 IU vitamin D32000 IU Vitamin D3 once/day for 2 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Students from Boston University Medical School
Key inclusion criteria (1 listed)
- Male and female adults of all races ages 18 years and older
Key exclusion criteria (8 listed)
- 1. Pregnant and lactating women.
- 2. Current or recent history of hepatic or renal disease
- 3. History of taking a daily supplement that contains more than 400 IU vitamin D2 or vitamin D3 within the past month or taking a pharmacologic amount of vitamin D2 or one of the active vitamin D analogs including Zemplar (Paricalcitol), Dovonex (calcipotriol), Hectorol (vitamin D pro hormone)
- 4. Subjects who are taking antiseizure medications or glucocorticoids.
- 5. Exposure to a tanning bed or tanning on a beach for more than eight hours within the past month.
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 |
|---|---|---|
| 400 IU vitamin D3Take 400 IU once/day for 2 months | Dietary supplement | Arm A |
| 2000 IU vitamin D32000 IU vitamin D3 once/day for 2 months | Dietary supplement | Arm B |
Primary outcome
Gene Expression
Time frame: Baseline and Final Visits
Measurement of mRNA levels from genes specific to bone, calcium, and non-skeletal functions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 23527013Hossein-nezhad A, Spira A, Holick MF. Influence of vitamin D status and vitamin D3 supplementation on genome wide expression of white blood cells: a randomized double-blind clinical trial. PLoS One. 2013;8(3):e58725. doi: 10.1371/journal.pone.0058725. Epub 2013 Mar 20.
- Individual participant dataSharing planned: No
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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.
Michael F Holick, PhD, MD principal investigator
BUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Boston University 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 1 inclusion and 8 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 4 Apr 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gene Expression (time frame: Baseline and Final Visits). 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 NCT01696409, which also lists 1 linked publication.
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 4 Apr 2017.