Almond Milk With Vitamin D: Impact on Vitamin D Status

Study Overview
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Brief Summary
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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.

Official Title
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Almond Milk With Vitamin D: Impact on Vitamin D Status

Conditions
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Renal Insufficiency, Chronic, Kidney Failure, Chronic

Intervention / Treatment
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* Dietary Supplement: NanoD4CKD
* Dietary Supplement: MicroD4CKD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized comparator-controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Based on estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the nanoparticle group. | Dietary Supplement: NanoD4CKD<br>* 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.<br>|
| Active Comparator: Comparator<br>Based on the estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the microparticle group. | Dietary Supplement: MicroD4CKD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |