The Effect Of Vitamin D On Measures Of Bone Health And Gene Expression
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01696409 |
Recruitment Status :
Completed
First Posted : October 1, 2012
Last Update Posted : April 4, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Vitamin D Deficiency | Dietary Supplement: 400 IU vitamin D3 Dietary Supplement: 2000 IU vitamin D3 |
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 |

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 |
- 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

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, Learn About Clinical Studies.
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 |
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

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
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Michael F Holick, PhD, MD | BUMC |
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 |
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Ergocalciferols |
Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |