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

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ClinicalTrials.gov Identifier: NCT01013584
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : June 26, 2012
Information provided by (Responsible Party):
Creighton University

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.

Condition or disease Intervention/treatment Phase
Obesity Vitamin D Deficiency Dietary Supplement: cholecalciferol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Weight on Vitamin D Dose Response
Study Start Date : November 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1,000 IU
1,000 IU/day of vitamin D3
Dietary Supplement: cholecalciferol
daily dose

Active Comparator: 5,000 IU
5,000 IU/day of vitamin D3
Dietary Supplement: cholecalciferol
daily dose

Active Comparator: 10,000 IU
10,000 IU/day of vitamin D3
Dietary Supplement: cholecalciferol
daily dose

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013584

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United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
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Principal Investigator: Andjela Drincic, MD Creighton University
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Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01013584    
Other Study ID Numbers: Creighton 8
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012
Keywords provided by Creighton University:
vitamin D
Additional relevant MeSH terms:
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Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents