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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael F. Holick, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01696409
First received: June 25, 2012
Last updated: October 1, 2012
Last verified: September 2012
  Purpose

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 Intervention
Vitamin D Deficiency
Dietary Supplement: 400 IU vitamin D3
Dietary Supplement: 2000 IU vitamin D3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Vitamin D on Measures of Bone Health and Gene Expression

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Gene Expression [ Time Frame: Baseline and Final Visits ] [ Designated as safety issue: No ]
    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.


Enrollment: 11
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy Students from Boston University Medical School

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696409

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Michael F Holick, PhD, MD BUMC
  More Information

No publications provided by Boston Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael F. Holick, Dr. Michael Holick, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01696409     History of Changes
Other Study ID Numbers: Vitamin D and Gene Expression
Study First Received: June 25, 2012
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 19, 2014