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Almond Milk With Vitamin D: Impact on Vitamin D Status

Primary Purpose

Renal Insufficiency, Chronic, Kidney Failure, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NanoD4CKD
MicroD4CKD
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Calcium
baseline to end line in the concentration of serum calcium between and within the control and intervention groups.
PTH
baseline to end line in the concentration of serum PTH between and within the control and intervention groups.
parent vitamin D
baseline to end line in the concentration of serum parent vitamin D between and within the control and intervention groups.
IL-6
baseline to end line in the concentration of serum IL-6 between and within the control and intervention groups.
C-reactive protein
baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups.
TNF-alpha
baseline to end line in the concentration of serum TNF-alpha between and within the control and intervention groups.

Full Information

First Posted
December 17, 2021
Last Updated
July 25, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05165173
Brief Title
Almond Milk With Vitamin D: Impact on Vitamin D Status
Official Title
Almond Milk With Vitamin D: Impact on Vitamin D Status
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
December 23, 2024 (Anticipated)
Study Completion Date
December 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Kidney Failure, Chronic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized comparator-controlled trial
Masking
ParticipantInvestigator
Masking Description
Participants will receive a coded sample that either contains 4000 IUs microparticles of vitamin D or 4000 IUs nanoparticles of vitamin D
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Based on estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the nanoparticle group.
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Based on the estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the microparticle group.
Intervention Type
Dietary Supplement
Intervention Name(s)
NanoD4CKD
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
MicroD4CKD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vitamin D
Description
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 Outcome Measure Information:
Title
Calcium
Description
baseline to end line in the concentration of serum calcium between and within the control and intervention groups.
Time Frame
21 days
Title
PTH
Description
baseline to end line in the concentration of serum PTH between and within the control and intervention groups.
Time Frame
21 days
Title
parent vitamin D
Description
baseline to end line in the concentration of serum parent vitamin D between and within the control and intervention groups.
Time Frame
21 days
Title
IL-6
Description
baseline to end line in the concentration of serum IL-6 between and within the control and intervention groups.
Time Frame
21 days
Title
C-reactive protein
Description
baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups.
Time Frame
21 days
Title
TNF-alpha
Description
baseline to end line in the concentration of serum TNF-alpha between and within the control and intervention groups.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanette M Andrade, PhD
Phone
3522943975
Email
jandrade1@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette Andrade, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanette M Andrade, PhD
Phone
352-294-3975
Email
jandrade1@ufl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Almond Milk With Vitamin D: Impact on Vitamin D Status

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