Clinical Trials Directory

Trials / Completed

CompletedNCT01013584

The Effect of Weight on Vitamin D Dose Response

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
67 (actual)
Sponsor
Creighton University · Academic / Other
Sex
Male
Age
19 Years – 60 Years
Healthy volunteers
Accepted

Summary

Vitamin D3 is a vitamin that is an essential component of biological regulating systems in humans. Sun exposure is the predominant source of vitamin D3. Previous research has shown that vitamin D3 deficiency is common worldwide. It is especially common in northern countries with long winters due to inadequate sun exposure during winter. In the US, an estimated 36% to 57% of healthy middle-aged to elderly adults have vitamin D3 deficiency. Current research indicates that obesity is associated with a low vitamin D3 level.

Detailed description

Obesity is a known risk factor for vitamin D deficiency. Adequate levels of vitamin D are important, not only for bone health, but appear to be important for prevention of certain autoimmune diseases, infections and cancers. Current FDA recommendations for vitamin D intake do not differentiate between lean and obese people. There are no published studies indicating if the 25(OH)D response to a given daily dose of vitamin D is any less in an obese person than a normal weight person. The purpose of this study is to characterize the quantitative relationship between steady state cholecalciferol input and the resulting serum 25 (OH)D concentration in obese subjects. Data obtained in this study will be compared to published normative data for non-obese subjects. Recommendations will be provided for optimal treatment of vitamin D deficiency in obese men and women.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTcholecalciferoldaily dose

Timeline

Start date
2009-11-01
Primary completion
2011-06-01
Completion
2011-07-01
First posted
2009-11-13
Last updated
2012-06-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01013584. Inclusion in this directory is not an endorsement.