Almond Milk With Vitamin D: Impact on Vitamin D Status

Kidney Failure, Chronic Clinical Trial

Official title:

Almond Milk With Vitamin D: Impact on Vitamin D Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165173
• Other study ID #: IRB202102986
• Secondary ID: OCR41655
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: November 18, 2023

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 18, 2023
• Est. primary completion date: November 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Calcium	baseline to end line in the concentration of serum calcium between and within the control and intervention groups.	21 days
Secondary	PTH	baseline to end line in the concentration of serum PTH between and within the control and intervention groups.	21 days
Secondary	parent vitamin D	baseline to end line in the concentration of serum parent vitamin D between and within the control and intervention groups.	21 days
Secondary	IL-6	baseline to end line in the concentration of serum IL-6 between and within the control and intervention groups.	21 days
Secondary	C-reactive protein	baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups.	21 days
Secondary	TNF-alpha	baseline to end line in the concentration of serum TNF-alpha between and within the control and intervention groups.	21 days