Almond Milk With Vitamin D: Impact on Vitamin D Status

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic; Renal Insufficiency, Chronic
• Interventions: Dietary Supplement: NanoD4CKD; Dietary Supplement: MicroD4CKD

• Registration Number: NCT05165173
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2021-12-21
• Study Start: 2023-05-22
• Primary Completion: 2023-11-18
• Study Completion: 2023-11-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	NanoD4CKD	Based on estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the nanoparticle group.
Comparator	MicroD4CKD	Based on the estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the microparticle group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Calcium	21 days	baseline to end line in the concentration of serum calcium between and within the control and intervention groups.
PTH	21 days	baseline to end line in the concentration of serum PTH 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.
TNF-alpha	21 days	baseline to end line in the concentration of serum TNF-alpha 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.
C-reactive protein	21 days	baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States