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| Name | Class |
|---|---|
| Winthrop University Hospital | OTHER |
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Although the African-American (AA) population tends to have lower serum 25(OH)D levels compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans are harmful. In fact, skeletal health is superior in AA. It is clear that total serum 25(OH)D concentrations do not reflect the same risk/benefit ratio in AA compared to white women and is, therefore, an inappropriate biomarker in this population.
The investigators wish to investigate whether free 25(OD)D and Vitamin D Metabolite Ratio (VMR, ratio of 25(OH)D to 24,25(OH)2D) are preferable biomarkers to total 25(OH)D. The investigators propose a six month randomized double blinded study.
The specific aims of this study are as follows:
The study population is postmenopausal Caucasian women age 60 and older. This six month study includes four visits. These results will be compared to those from a study in AA women which the investigators are also completing.
There are two study groups. One group will receive vitamin D supplementation, the other a placebo. Subjects will be asked to refrain from taking outside Vitamin D supplements for the duration of the study. If the subject is eligible based on the results from the first two visits, the subject will be randomized into one of these two groups. Randomized subjects will be taking the vitamin D or placebo for a period of 6 months and will have one visit at the 3 month mark and a final visit at the 6 month mark.
At the 3-month visit, the following procedures will be conducted: obtain interim medical and travel history, vital signs, weight, and height measured by the Harpenden Stadiometer, record adverse events and concomitant medications, Fasting blood collection: total 25(OH)D (by Diasorin), PTH, serum calcium and creatinine, Fasting urine collection for calcium and creatinine, and questionnaires: calcium food frequency questionnaire, quality of life questionnaire, falls and flu questionnaires. Subjects will be instructed on how to collect a 24-hour urine sample (for final visit) and collection container will be dispensed. Unused study supplements will be collected and counted, and study supplements will be dispensed based on serum 25(OH)D level algorithm.
At the 6-month visit, in addition to what is completed at the 3-month visit, the following procedures will also be conducted:24-hour urine calcium, sodium, oxalate and creatinine; mini-mental health examination; physical performance examination (SPPB); and a physical activity questionnaire. Unused study supplements will be collected and counted. No further supplementation will be provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D Supplementation | Experimental | Participant will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level. If subject has insufficient dietary calcium intake, calcium supplementation will be provided in the form of one 600mg CaCO3 pill to achieve a total calcium intake of 1200mg/day. |
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| Placebo | Placebo Comparator | Participant will receive a placebo. If subject has insufficient dietary calcium intake, calcium supplementation will be provided in the form of one 600mg CaCO3 pill to achieve a total calcium intake of 1200mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D Supplementation | Dietary Supplement | Subjects in this group will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare free 25(OH)D levels in Caucasian women (current study) and AA women (from prior study) | VDBP will be measured and free 25(OH)D calculated | baseline |
| Compare Vitamin D metabolite ratio (VMR) in Caucasian women (current study) and AA women (from prior study) | serum 24,25(OH)2D and serum 25(OH)D will be measured and VMR calculated | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between free 25(OH)D and two measures of bone health (PTH and BMD) | Relationships will be assessed via correlation and regression analyses | baseline |
| Relationship between VMR and two measures of bone health (PTH and BMD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Aloia, MD | Winthrop University Hospital | Principal Investigator |
| Mageda Mikhail, MD | Winthrop University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Placebo | Other | Subjects in this group will receive a placebo. |
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| Calcium | Dietary Supplement | If dietary calcium intake is insufficient in participants of either group, they will be given a calcium supplement in the form of one 600mg pill of CaCO3 to bring them up to an intake of 1200mg/day. |
|
Relationships will be assessed via correlation and regression analyses
| baseline |
| Relationship between vitamin D intake and Change in Physical Performance Assessment (SPPB) | Relationships will be assessed via Mixed-Effects Model for Repeated Measures (MMRM) | baseline and 6 months |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |