Almond Milk With Vitamin D: Impact on Vitamin D Status

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05165173

Collaborator

(none)

Enrollment

Location

Arms

26.7

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency, Chronic Kidney Failure, Chronic	Dietary Supplement: NanoD4CKD Dietary Supplement: MicroD4CKD	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized comparator-controlled trialrandomized comparator-controlled trial

Masking:

Double (Participant, 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

Primary Purpose:

Basic Science

Official Title:

Almond Milk With Vitamin D: Impact on Vitamin D Status

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 23, 2024

Anticipated Study Completion Date :

Dec 23, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention

Based on estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the nanoparticle group.

Dietary Supplement: NanoD4CKD

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.

Active Comparator: Comparator

Based on the estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the microparticle group.

Dietary Supplement: MicroD4CKD

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
IL-6 [21 days]
baseline to end line in the concentration of serum IL-6 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32606

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Jeanette Andrade, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeanette Andrade, Assistant Professor, University of Florida

ClinicalTrials.gov Identifier:

NCT05165173

Other Study ID Numbers:

IRB202102986
OCR41655

First Posted:

Dec 21, 2021

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Kidney Failure, Chronic

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Jul 8, 2022