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Enable to further recruit study subjects
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Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies were done with non-obese subjects. This study looks at vitamin D supplementation requirements in obese patients as compared to non-obese subjects. This study also looks at changes in vitamin D level in obese patients undergoing medical weight loss. It is thought that obese patients have vitamin D deficiency through storage of vitamin D in the fat compartment not readily available for blood measurement. The investigators' hypothesis is that with medical weight loss vitamin D levels will increase in obese subjects.
We intend to study changes in serum 25(OH)D level with calorie restricted weight loss in obese subjects. This will be a double dummy, placebo controlled randomized trial. Subjects whose serum 25(OH)D level is below 80 nmol/L will be assigned randomly to either the vitamin D supplemented or the placebo group. Those who are assigned to the placebo group will be weighed on a weekly basis and serum 25(OH)D level will be followed every 8 weeks for a minimum of 16 weeks and extended to the duration of weight loss along with serum calcium level. Changes in serum 25(OH)D level will be obtained with weight loss through restricted caloric intake.
To study the 25(OH)D dose-response curve with vitamin D supplementation in obese subjects, vitamin D supplemented group will receive initial daily vitamin D3 supplementation dose based on their baseline serum 25(OH)D level as described in Methods and Procedures section. Serum 25(OH)D levels will be drawn at 8 weeks and adjustments to the dose will be made based on the an algorithm to achieve serum 25(OH)D levels between 80 and 140 nmol/L. The dose-response curve obtained at 8 weeks will be compared to the one already established with non-obese subjects. Serum 25(OH)D level will be obtained at 16 weeks and compared with the data available from non-obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Half of subjects will be randomized to the placebo group. |
|
| Vitamin D3 | Active Comparator | This is the study group that receives Vitamin D supplementation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Level of 25(OH)D | Vitamin D (25(OH)D) level at Baseline. | Baseline |
| Mean Level of 25(OH)D | Vitamin D (25(OH)D) level at Month 2. | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Aloia,, MD | Winthrop-Unviersity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
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Participants underwent a comprehensive history and physical examination and provides a blood specimen for laboratory measurements at baseline. Participants with 25(OH)D greater or equal to 80nmol/L at baseline were excluded from the study. The anticipated enrollment of 39 was an error.
Volunteers were recruited during the winter months from areas in a surrounding Long Island, New York by advertisement through flyers and direct mail. Volunteers were 18-65 years old with a BMI of >35kg/m2. Recruitment began in January of 2009 at the Bone Mineral Research Center at Winthrop University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Half of subjects will be randomized to the placebo group. placebo: The placebo group will receive sugar pills appearing similar to the vitamin D capsules. |
| FG001 | Vitamin D3 | This is the study group that receives Vitamin D supplementation. Vitamin D3: Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Half of subjects will be randomized to the placebo group. placebo: The placebo group will receive sugar pills appearing similar to the vitamin D capsules. |
| BG001 | Vitamin D3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Level of 25(OH)D | Vitamin D (25(OH)D) level at Baseline. | Posted | Mean | Standard Deviation | nmol/L | Baseline |
|
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Adverse events were collected from the date the patient started the study medications until the date they completed the study, typically 2 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Half of subjects will be randomized to the placebo group. placebo: The placebo group will receive sugar pills appearing similar to the vitamin D capsules. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Aloia, MD | Winthrop-University Hospital | 516-663-2442 | jaloia@winthrop.org |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| placebo | Drug | The placebo group will receive sugar pills appearing similar to the vitamin D capsules. |
|
This is the study group that receives Vitamin D supplementation.
Vitamin D3: Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Mean Level of 25(OH)D | Vitamin D (25(OH)D) level at Month 2. | Posted | Mean | Standard Deviation | nmol/L | Week 8 |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Vitamin D3 | This is the study group that receives Vitamin D supplementation. Vitamin D3: Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day. | 0 | 14 | 0 | 14 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |