The Effect Of Vitamin D On Measures Of Bone Health And Gene Expression
The Effect of Vitamin D on Measures of Bone Health and Gene Expression
1 other identifier
observational
11
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 1, 2012
CompletedApril 4, 2017
April 1, 2017
2.9 years
June 25, 2012
April 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Gene Expression
Measurement of mRNA levels from genes specific to bone, calcium, and non-skeletal functions.
Baseline and Final Visits
Study Arms (2)
Arm A
400 IU vitamin D3 once a day for 2 months
Arm B
2000 IU Vitamin D3 once/day for 2 months
Interventions
Eligibility Criteria
Healthy Students from Boston University Medical School
You may qualify if:
- Male and female adults of all races ages 18 years and older
You may not qualify if:
- \. Pregnant and lactating women.
- \. Current or recent history of hepatic or renal disease
- \. 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)
- \. Subjects who are taking antiseizure medications or glucocorticoids.
- \. Exposure to a tanning bed or tanning on a beach for more than eight hours within the past month.
- \. Known history of elevated calcium. (\> 10.5 mg% (mg/dl))
- \. History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat Malabsorption Syndrome, Crohn's Disease)
- \. Unwilling to consent to this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (1)
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.
PMID: 23527013DERIVED
Biospecimen
Buffy coat has been retained from whole blood.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael F Holick, PhD, MD
BUMC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Michael Holick
Study Record Dates
First Submitted
June 25, 2012
First Posted
October 1, 2012
Study Start
July 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
April 4, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share