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The Effect of Weight on Vitamin D Dose Response

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01013584
First received: November 12, 2009
Last updated: June 25, 2012
Last verified: June 2012

November 12, 2009
June 25, 2012
November 2009
June 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01013584 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Weight on Vitamin D Dose Response
The Effect of Weight on Vitamin D Dose Response

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Obesity
  • Vitamin D Deficiency
Dietary Supplement: cholecalciferol
daily dose
  • Active Comparator: 1,000 IU
    1,000 IU/day of vitamin D3
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: 5,000 IU
    5,000 IU/day of vitamin D3
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: 10,000 IU
    10,000 IU/day of vitamin D3
    Intervention: Dietary Supplement: cholecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
July 2011
June 2011   (final data collection date for primary outcome measure)

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.
Male
19 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01013584
Creighton 8
No
Creighton University
Creighton University
Not Provided
Principal Investigator: Andjela Drincic, MD Creighton University
Creighton University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP