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The Effect of Weight on Vitamin D Dose Response (Weight)

Primary Purpose

Obesity, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring vitamin D

Eligibility Criteria

19 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • men aged 19 to 60 with BMI > 30.0.
  • They will have low (<1,000 IU) usual intake of vitamin D (from milk, multivitamins, supplements, and fortified foods)

Exclusion Criteria:

  • Subjects will not have history of hepatic or renal disease.
  • Subjects will not be taking medications known to affect vitamin D metabolism such as anti-seizure medications and/or corticosteroids.
  • They will not be on hydrochlorothiazide medications which could cause hypercalcemia.
  • They will not have diseases causing malabsorption of vitamin D, such as celiac sprue or small bowel surgeries.
  • Pregnancy is also an exclusion criterion.

Sites / Locations

  • Creighton University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1,000 IU

5,000 IU

10,000 IU

Arm Description

1,000 IU/day of vitamin D3

5,000 IU/day of vitamin D3

10,000 IU/day of vitamin D3

Outcomes

Primary Outcome Measures

To characterize the dose response of 25(OH)D to 1,000, 5,000 or 10,000 IU/day of vitamin D3 for 21 weeks in a group of obese men and women.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2009
Last Updated
June 25, 2012
Sponsor
Creighton University
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1. Study Identification

Unique Protocol Identification Number
NCT01013584
Brief Title
The Effect of Weight on Vitamin D Dose Response
Acronym
Weight
Official Title
The Effect of Weight on Vitamin D Dose Response
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Vitamin D Deficiency
Keywords
vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1,000 IU
Arm Type
Active Comparator
Arm Description
1,000 IU/day of vitamin D3
Arm Title
5,000 IU
Arm Type
Active Comparator
Arm Description
5,000 IU/day of vitamin D3
Arm Title
10,000 IU
Arm Type
Active Comparator
Arm Description
10,000 IU/day of vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Intervention Description
daily dose
Primary Outcome Measure Information:
Title
To characterize the dose response of 25(OH)D to 1,000, 5,000 or 10,000 IU/day of vitamin D3 for 21 weeks in a group of obese men and women.
Time Frame
21 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: men aged 19 to 60 with BMI > 30.0. They will have low (<1,000 IU) usual intake of vitamin D (from milk, multivitamins, supplements, and fortified foods) Exclusion Criteria: Subjects will not have history of hepatic or renal disease. Subjects will not be taking medications known to affect vitamin D metabolism such as anti-seizure medications and/or corticosteroids. They will not be on hydrochlorothiazide medications which could cause hypercalcemia. They will not have diseases causing malabsorption of vitamin D, such as celiac sprue or small bowel surgeries. Pregnancy is also an exclusion criterion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andjela Drincic, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

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The Effect of Weight on Vitamin D Dose Response

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