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| ID | Type | Description | Link |
|---|---|---|---|
| OCR41655 | Other Identifier | UF OnCore |
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The overall goal is to enhance vitamin D status in a safe and effective manner. A 3-week randomized comparator-controlled trial among a cohort of adults with CKD (stages 3-5) (n=24) will test the main objective: Evaluate the bioefficacy of D3 in micro- and nanoparticles (4000IUs) in almond milk with the sub-objective of: Explore the effect of D3 in micro- and nanoparticles (4000IUs) in almond milk on inflammation markers CRP, TNF-α and IL-6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Based on estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the nanoparticle group. |
|
| Comparator | Active Comparator | Based on the estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the microparticle group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoD4CKD | Dietary Supplement | Participants will receive a 7-day supply of the 4-ounce almond milk mixed with 4000 IUs of nanoparticles of D3 and instructed to consume it in the morning with a meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D | baseline to end line in the concentration of serum 25(OH)D3 between and within the control and intervention groups. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Calcium | baseline to end line in the concentration of serum calcium between and within the control and intervention groups. | 21 days |
| PTH | baseline to end line in the concentration of serum PTH between and within the control and intervention groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanette Andrade, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32606 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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randomized comparator-controlled trial
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Participants will receive a coded sample that either contains 4000 IUs microparticles of vitamin D or 4000 IUs nanoparticles of vitamin D
| MicroD4CKD | Dietary Supplement | Participants will receive a 7-day supply of the 4-ounce almond milk mixed with 4000 IUs of microparticles of D3 and instructed to consume it in the morning with a meal. |
|
| 21 days |
| parent vitamin D | baseline to end line in the concentration of serum parent vitamin D between and within the control and intervention groups. | 21 days |
| IL-6 | baseline to end line in the concentration of serum IL-6 between and within the control and intervention groups. | 21 days |
| C-reactive protein | baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups. | 21 days |
| TNF-alpha | baseline to end line in the concentration of serum TNF-alpha between and within the control and intervention groups. | 21 days |
| 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 |