The Effect of Weight on Vitamin D Dose Response

NCT01013584 | Completed

• 1 other identifier: Creighton 8
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Vitamin D Deficiency

Keywords

vitamin D

Outcome Measures

Primary Outcomes (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.

  21 weeks

Study Arms (3)

1,000 IU

ACTIVE COMPARATOR

1,000 IU/day of vitamin D3

Dietary Supplement: cholecalciferol

5,000 IU

ACTIVE COMPARATOR

5,000 IU/day of vitamin D3

Dietary Supplement: cholecalciferol

10,000 IU

ACTIVE COMPARATOR

10,000 IU/day of vitamin D3

Dietary Supplement: cholecalciferol

Interventions

cholecalciferol DIETARY_SUPPLEMENT

daily dose

1,000 IU; 10,000 IU; 5,000 IU

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Obesity; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Andjela Drincic, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 13, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

US (1)