- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00960037
Trial to Assess Response to Oral Vitamin D3 Supplementation in Obese Individuals
June 14, 2012 updated by: John F. Aloia, MD, Winthrop University Hospital
The Vitamin D Dose Response Curve in Obesity
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Mineola, New York, United States, 11501
- Winthrop University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
One capsule daily for 8 weeks
|
Experimental: Vitamin D
Vitamin D3 supplementation based on baseline 25(OH)D level
|
Vitamin D3 50-100 mcg capsule(depending on baseline serum 25(OH)D concentration) daily for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in serum 25(OH)D level from baseline.
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John F Aloia, MD, Winthrop University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
August 13, 2009
First Submitted That Met QC Criteria
August 14, 2009
First Posted (Estimate)
August 17, 2009
Study Record Updates
Last Update Posted (Estimate)
June 18, 2012
Last Update Submitted That Met QC Criteria
June 14, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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