Almond Milk With Vitamin D: Impact on Vitamin D Status

University of Florida21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Renal Insufficiency, Chronic Kidney Failure, Chronic

Interventions

NanoD4CKDDIETARY_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.

MicroD4CKDDIETARY_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Vitamin D

baseline to end line in the concentration of serum 25(OH)D3 between and within the control and intervention groups.

Time frame: 21 days

Secondary Outcomes

Calcium

baseline to end line in the concentration of serum calcium between and within the control and intervention groups.

Time frame: 21 days

PTH

baseline to end line in the concentration of serum PTH between and within the control and intervention groups.

Time frame: 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.

Time frame: 21 days

IL-6

baseline to end line in the concentration of serum IL-6 between and within the control and intervention groups.

Time frame: 21 days

C-reactive protein

baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups.

Time frame: 21 days

TNF-alpha

baseline to end line in the concentration of serum TNF-alpha between and within the control and intervention groups.

Time frame: 21 days

Data from ClinicalTrials.gov

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