Almond Milk With Vitamin D: Impact on Vitamin D Status

University of Florida

Status: Completed

Conditions: Kidney Failure, Chronic; Renal Insufficiency, Chronic

Treatments: Dietary Supplement: NanoD4CKD; Dietary Supplement: MicroD4CKD

Study type: Interventional

Funder types: Other

Identifiers

NCT05165173

OCR41655 (Other Identifier)

IRB202102986

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: NanoD4CKD

Comparator

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: MicroD4CKD