Almond Milk With Vitamin D: Impact on Vitamin D Status

Last updated: June 7, 2024
Sponsor: University of Florida
Overall Status: Completed

Phase

N/A

Condition

Nephropathy

Kidney Failure (Pediatric)

Renal Failure

Treatment

MicroD4CKD

NanoD4CKD

Clinical Study ID

NCT05165173
IRB202102986
OCR41655
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 21
Treatment Group(s): 2
Primary Treatment: MicroD4CKD
Phase:
Study Start date:
May 22, 2023
Estimated Completion Date:
November 18, 2023

Connect with a study center

  • University of Florida

    Gainesville, Florida 32606
    United States

    Site Not Available

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