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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50AR063020-01 | U.S. NIH Grant/Contract | View source | |
| UL1TR000124 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The purpose of this study is to compare the effects of two different forms of vitamin D supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the blood, and on markers of skeletal and immune health. This study is designed as a pilot study. A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12 Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a screening visit during which a medical history will be taken, a physical exam performed, a dietary questionnaire administered, and blood collected. The purpose of the screening visit is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After initiating supplementation, study patients will return for follow-up visits at weeks 4, 8, and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as well as markers of skeletal and immune function. Participation in this study will therefore involve a total of 5 visits (1 screening visit, 1 randomization visit during which participants will receive their study supplements, 3 follow-up visits). After all data is collected, changes in vitamin D levels in the blood following supplementation with either vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance and immune function. Knowledge gained from this study may have a significant impact on how vitamin D status is defined, and how vitamin D repletion is administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25(OH)D3 | Experimental | 20 micrograms/day by mouth for 16 weeks |
|
| Vitamin D3 | Experimental | 2,400 IU/day by mouth for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | 2400 IU/day by mouth for 16 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in total serum 25D | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum free 25D | 16 weeks | |
| Change in serum total 1,25D | 16 weeks | |
| Change in total free 1,25D |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John S Adams, MD | University of California, Los Angeles Department of Orhtopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Clinical and Translational Research Center (CTRC) | Los Angeles | California | 90095 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34343292 | Derived | Shieh A, Lee SM, Lagishetty V, Gottleib C, Jacobs JP, Adams JS. Pilot Trial of Vitamin D3 and Calcifediol in Healthy Vitamin D Deficient Adults: Does It Change the Fecal Microbiome? J Clin Endocrinol Metab. 2021 Nov 19;106(12):3464-3476. doi: 10.1210/clinem/dgab573. | |
| 29931358 | Derived | Shieh A, Ma C, Chun RF, Wittwer-Schegg J, Swinkels L, Huijs T, Wang J, Donangelo I, Hewison M, Adams JS. Associations Between Change in Total and Free 25-Hydroxyvitamin D With 24,25-Dihydroxyvitamin D and Parathyroid Hormone. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3368-3375. doi: 10.1210/jc.2018-00515. |
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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 |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| D002112 | Calcifediol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| 25(OH)D3 | Drug | 20 micrograms/day by mouth for 16 weeks |
|
|
| 16 weeks |
| Change in serum calcium | 16 weeks |
| Change in urinary calcium | 16 weeks |
| Change in serum iPTH | 16 weeks |
| Change in serum bone turnover markers | 16 weeks |
| Change in markers of immune function | 16 weeks |
| University of California, Los Angeles |
| Los Angeles |
| California |
| 90095 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D006887 | Hydroxycholecalciferols |