Almond Milk With Vitamin D: Impact on Vitamin D Status

NCT05165173 | Completed

• 2 other identifiers: IRB202102986OCR41655
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Calcium

  21 days

• PTH

  21 days

• parent vitamin D

  21 days

• IL-6

  21 days

• C-reactive protein

  21 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: NanoD4CKD

Comparator

ACTIVE COMPARATOR

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

Dietary Supplement: MicroD4CKD

Interventions

NanoD4CKD DIETARY_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.

Intervention

MicroD4CKD DIETARY_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.

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeanette Andrade, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will receive a coded sample that either contains 4000 IUs microparticles of vitamin D or 4000 IUs nanoparticles of vitamin D
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized comparator-controlled trial

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: December 21, 2021
• Study Start: May 22, 2023
• Primary Completion: November 18, 2023
• Study Completion: November 18, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)