Trial to Assess Response to Oral Vitamin D3 Supplementation in Obese Individuals

NCT00960037 | Completed

• 1 other identifier: 08002
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an extension of an earlier study of vitamin D supplementation conducted on normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop University Hospital. The investigators plan to compare the response to vitamin D supplementation in obese individuals with the response already measured in normal weight individuals. The same dosing schedule of vitamin supplementation will be used as in the past. The doses used in the past have demonstrated safety in a number of trials, here at Winthrop as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in the study. The study participants will mainly be recruited from a group of patients who have in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be measured before and at the end of the supplementation period. They will then be compared to see the change over time as a result of supplementation.

Conditions

Obesity

Keywords

Vitamin D3; obesity; cholecalciferol

Outcome Measures

Primary Outcomes (1)

• Change in serum 25(OH)D level from baseline.

  8 weeks

Study Arms (2)

Vitamin D

EXPERIMENTAL

Vitamin D3 supplementation based on baseline 25(OH)D level

Dietary Supplement: Oral vitamin D3

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo equivalent

Interventions

Oral vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 50-100 mcg capsule(depending on baseline serum 25(OH)D concentration) daily for 8 weeks.

Vitamin D

Placebo equivalent DIETARY_SUPPLEMENT

One capsule daily for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• obese adults aged 18-65 years and BMI\>35

You may not qualify if:

• chronic medical illness (diabetes, malignancy, uncontrolled hypertension, kidney disease)
• subjects who have undergone bariatric surgery or currently enrolled in a medically supervised weight loss program
• BMI \< 35
• pregnancy
• use of medication that influences vitamin D metabolism
• history of of hypercalcemia, hypercalciuria, nephrolithiasis

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• John F Aloia, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bone Mineral Research Center

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 17, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 18, 2012

Record last verified: 2012-06

Locations

US (1)