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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy Students from Boston University Medical School

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene Expression	Measurement of mRNA levels from genes specific to bone, calcium, and non-skeletal functions.	Baseline and Final Visits

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Michael F Holick, PhD, MD, BUMC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: Vitamin D and Gene Expression

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No