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NCT00033826 Clinical Trial

Role of Fat Tissue in Vitamin D Metabolism

Vitamin D Clinical Trial

Official title:
The Role of Adipose Tissue in Vitamin D Metabolism

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00033826
Other study ID # K23AR047869
Secondary ID K23AR047869NIAMS
Status Completed
Phase N/A
First received April 10, 2002
Last updated May 23, 2013
Start date April 2002
Est. completion date September 2007

Study information
Verified date May 2013
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Vitamin D is a fat soluble vitamin that has important effects on calcium (including absorption of calcium from the diet) and bone metabolism. Vitamin D is known to be stored in fat tissue, and it is also present in the circulation. The purpose of this study is to investigate the relationship between levels of vitamin D in fat tissue and in blood.

Description:

Although vitamin D is known to be stored in fat tissue, researchers are not sure about the role that fat tissue plays in vitamin D metabolism. This study will help develop the methodology necessary to further investigate the role of fat tissue in vitamin D metabolism and will assess the relationship between levels of vitamin D in fat tissue and in blood. 50 subjects who are referred for gastric bypass surgery will be enrolled in this study. Subjects will complete questionnaires about their medical history, travel history and food intake. Prior to or during surgery, subjects will be asked to provide a blood sample for selected chemistries related to vitamin D metabolism. During gastric bypass surgery, the surgeon will collect small pieces of fat tissue from the fat under the skin and within the abdomen by surgical biopsy. These samples will be used to refine the methodology for determining the levels of vitamin D in blood and fat tissue and for comparing levels of vitamin D in various tissues.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Obese patients referred for gastric bypass surgery

Exclusion Criteria:

- Patients must not be taking bile acid-sequestering medications or anti-seizure medications

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Tufts-New England Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Tufts University National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

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