The Effect Of Vitamin D On Measures Of Bone Health And Gene Expression

• ClinicalTrials.gov Identifier: NCT01696409
• Recruitment Status: Completed
• First Posted: October 1, 2012
• Last Update Posted: April 4, 2017
• Sponsor: Boston University
• Information provided by (Responsible Party): Michael F. Holick, Boston University

Tracking Information

• First Submitted Date: June 25, 2012
• First Posted Date: October 1, 2012
• Last Update Posted Date: April 4, 2017
• Study Start Date: July 2009
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 1, 2012)

Gene Expression [ Time Frame: Baseline and Final Visits ]

Measurement of mRNA levels from genes specific to bone, calcium, and non-skeletal functions.

Original Primary Outcome Measures (submitted: September 26, 2012)

Gene Expression [ Time Frame: Throughout the study ]

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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect Of Vitamin D On Measures Of Bone Health And Gene Expression
• Official Title: The Effect of Vitamin D on Measures of Bone Health and Gene Expression
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Buffy coat has been retained from whole blood.

• Sampling Method: Probability Sample
• Study Population: Healthy Students from Boston University Medical School
• Condition: Vitamin D Deficiency

Intervention

• Dietary Supplement: 400 IU vitamin D3
  Take 400 IU once/day for 2 months
• Dietary Supplement: 2000 IU vitamin D3
  2000 IU vitamin D3 once/day for 2 months

Study Groups/Cohorts

• Arm A
  400 IU vitamin D3 once a day for 2 months
  Intervention: Dietary Supplement: 400 IU vitamin D3
• Arm B
  2000 IU Vitamin D3 once/day for 2 months
  Intervention: Dietary Supplement: 2000 IU vitamin D3

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 26, 2012): 11
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male and female adults of all races ages 18 years and older

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01696409
• Other Study ID Numbers: Vitamin D and Gene Expression
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Michael F. Holick, Boston University
• Original Responsible Party: Michael F. Holick, Boston Medical Center, Dr. Michael Holick
• Current Study Sponsor: Boston University
• Original Study Sponsor: Boston Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael F Holick, PhD, MD; BUMC

• PRS Account: Boston University
• Verification Date: April 2017