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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00960037
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
John F. Aloia, MD, Winthrop University Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Oral vitamin D3 Dietary Supplement: Placebo equivalent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Vitamin D Dose Response Curve in Obesity
Study Start Date : January 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D
Vitamin D3 supplementation based on baseline 25(OH)D level
Dietary Supplement: Oral vitamin D3
Vitamin D3 50-100 mcg capsule(depending on baseline serum 25(OH)D concentration) daily for 8 weeks.

Placebo Comparator: Placebo Dietary Supplement: Placebo equivalent
One capsule daily for 8 weeks




Primary Outcome Measures :
  1. Change in serum 25(OH)D level from baseline. [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT00960037


Locations
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United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
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Principal Investigator: John F Aloia, MD Winthrop University Hospital

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Responsible Party: John F. Aloia, MD, Director, Bone Mineral Research Center, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00960037    
Other Study ID Numbers: 08002
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012
Keywords provided by John F. Aloia, MD, Winthrop University Hospital:
Vitamin D3
obesity
cholecalciferol
Additional relevant MeSH terms:
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Vitamin D
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents