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In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese women, and hypothesize that it will not affect areal BMD, but will alter bone compartments (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum 25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes include the influence of vitamin D and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600 IU D3 | Placebo Comparator |
| |
| 2000 IU D3 | Active Comparator |
| |
| 4000 IU D3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 600 IU Vitamin D3 | Dietary Supplement | Once daily |
| |
| 2000 IU Vitamin D3 |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density (BMD) | BMD | 1 year |
| Bone quality | thickness (mm) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Bone turnover markers | osteocalcin (others include PINP and CTX) | Baseline, 6 months, 12 months |
| Glycemic indices | glucose and insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Shapses, PhD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University- Thompson Hall | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30951148 | Background | Castle M, Fiedler N, Pop LC, Schneider SJ, Schlussel Y, Sukumar D, Hao L, Shapses SA. Three Doses of Vitamin D and Cognitive Outcomes in Older Women: A Double-Blind Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):835-842. doi: 10.1093/gerona/glz041. | |
| 27535752 | Background | Pop LC, Sukumar D, Schneider SH, Schlussel Y, Stahl T, Gordon C, Wang X, Papathomas TV, Shapses SA. Three doses of vitamin D, bone mineral density, and geometry in older women during modest weight control in a 1-year randomized controlled trial. Osteoporos Int. 2017 Jan;28(1):377-388. doi: 10.1007/s00198-016-3735-z. Epub 2016 Aug 17. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 5, 2026 | |
| Reset | Jun 30, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 5, 2026 | Jun 30, 2026 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Dietary Supplement |
Once daily |
|
| 4000 IU Vitamin D3 | Dietary Supplement | Once daily |
|
| Baseline, 6 months and 12 months |
| Cognition and biochemical markers | Cognitive measures and serum biochemical markers | One year |
| cholesterol absorption | Serum levels | baseline and one year |
| serum vitamin D | 25(OH)D | Baseline, 6 months and 12 months |
| Bone regulating hormones | PTH | Baseline, 6 months and 12 months |
| 35538903 | Derived | Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |