Kidney Failure, Chronic, Renal Insufficiency, Chronic
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNanoD4CKD
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.
DIETARY_SUPPLEMENTMicroD4CKD
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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants will receive a coded sample that either contains 4000 IUs microparticles of vitamin D or 4000 IUs nanoparticles of vitamin D
Intervention model description
randomized comparator-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults who have been diagnosed with CKD * have no GI disorders or GI disturbances * age 18 years or older * no food allergies or dietary restrictions * all with no contraindications to consuming anything by mouth as per their physician
Exclusion criteria
* no diagnosis of CKD * GI disorders * gastrointestinal disturbances * under 18 years old * food allergies to almonds * Dietary restrictions as medically indicated * trouble chewing/swallowing as confirmed by physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D | 21 days | baseline to end line in the concentration of serum 25(OH)D3 between and within the control and intervention groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTH | 21 days | baseline to end line in the concentration of serum PTH between and within the control and intervention groups. |
| parent vitamin D | 21 days | baseline to end line in the concentration of serum parent vitamin D between and within the control and intervention groups. |
| Calcium | 21 days | baseline to end line in the concentration of serum calcium between and within the control and intervention groups. |
| C-reactive protein | 21 days | baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups. |
| TNF-alpha | 21 days | baseline to end line in the concentration of serum TNF-alpha between and within the control and intervention groups. |
| IL-6 | 21 days | baseline to end line in the concentration of serum IL-6 between and within the control and intervention groups. |
Countries
United States
Outcome results
None listed