Completed

The Effect of Vitamin D on Measures of Bone Health and Gene Expression

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What is being collected

Dietary Supplement Data

+ dietarySupplement Data

Collected from today forward - Prospective
Dietary SupplementDNA Samples
Who is being recruted

Avitaminosis+3

+ Deficiency Diseases

+ Nutrition Disorders

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2009
See protocol details

Summary

Principal SponsorBoston University
Last updated: April 4, 2017
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Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

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.

Principal SponsorBoston University
Last updated: April 4, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AvitaminosisDeficiency DiseasesNutrition DisordersNutritional and Metabolic DiseasesMalnutritionVitamin D Deficiency

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Boston Medical Center

Boston, United StatesOpen Boston Medical Center in Google Maps
CompletedOne Study Center