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

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Nebraska

Creighton University

Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Investigators

• Principal Investigator: Andjela Drincic, MD; Creighton University

More Information

• Responsible Party: Creighton University
• ClinicalTrials.gov Identifier: NCT01013584
• Other Study ID Numbers: Creighton 8
• First Posted: November 13, 2009
• Last Update Posted: June 26, 2012
• Last Verified: June 2012

Keywords provided by Creighton University:

vitamin D

Additional relevant MeSH terms:

Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Cholecalciferol; Vitamin D; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vitamins; Micronutrients; Bone Density Conservation Agents