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| Name | Class |
|---|---|
| Dialysis Clinic, Inc. | INDUSTRY |
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Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.
The proposed study is be a randomized, double-blind, placebo-controlled trial of supplementation with oral vitamin D3.
Each subject will take a once-weekly capsule containing vitamin D3 or a an identical-appearing placebo for a treatment period of 15 weeks.
Subjects will be assessed for Bone pain and tenderness, Neuromuscular function, physical performance score, and Quality of life assessment.
A subset of subjects will have bone biopsies performed before and after intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Will receive 10,000 IU of cholecalciferol weekly |
|
| 2 | Placebo Comparator | Will receive a identical appearing placebo weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Dietary Supplement | 10,000 IU weekly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change in physical performance score | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bone pain and tenderness | 15 weeks | |
| Neuromuscular function tests | 15 weeks | |
| Quality of life assessment |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Lund, MD | Creighton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University | Omaha | Nebraska | 68178 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28506446 | Derived | Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D3 response to native vitamin D2 and D3 Supplementation in patients with chronic kidney disease on hemodialysis. Clin Nutr. 2018 Jun;37(3):1041-1045. doi: 10.1016/j.clnu.2017.04.020. Epub 2017 Apr 30. | |
| 22798536 | Derived | Armas LA, Andukuri R, Barger-Lux J, Heaney RP, Lund R. 25-Hydroxyvitamin D response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2012 Sep;7(9):1428-34. doi: 10.2215/CJN.12761211. Epub 2012 Jul 12. |
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| placebo | Dietary Supplement | placebo capsule |
|
| 15 weeks |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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