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

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

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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Dietary Supplement: 400 IU vitamin D3 Dietary Supplement: 2000 IU vitamin D3

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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Vitamin D on Measures of Bone Health and Gene Expression
Study Start Date : July 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Arm A
400 IU vitamin D3 once a day for 2 months
Dietary Supplement: 400 IU vitamin D3
Take 400 IU once/day for 2 months

Arm B
2000 IU Vitamin D3 once/day for 2 months
Dietary Supplement: 2000 IU vitamin D3
2000 IU vitamin D3 once/day for 2 months

Primary Outcome Measures :
  1. Gene Expression [ Time Frame: Baseline and Final Visits ]
    Measurement of mRNA levels from genes specific to bone, calcium, and non-skeletal functions.

Biospecimen Retention:   Samples With DNA
Buffy coat has been retained from whole blood.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Students from Boston University Medical School

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696409

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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
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Principal Investigator: Michael F Holick, PhD, MD BUMC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael F. Holick, Dr. Michael Holick, Boston University
ClinicalTrials.gov Identifier: NCT01696409    
Other Study ID Numbers: Vitamin D and Gene Expression
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents