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Completed

NCT Number: NCT05165173

Almond Milk With Vitamin D: Impact on Vitamin D Status

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Vitamin D

    Time frame: 21 days

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

Secondary outcomes

  1. Calcium

    Time frame: 21 days

    baseline to end line in the concentration of serum calcium between and within the control and intervention groups.

  2. PTH

    Time frame: 21 days

    baseline to end line in the concentration of serum PTH between and within the control and intervention groups.

  3. parent vitamin D

    Time frame: 21 days

    baseline to end line in the concentration of serum parent vitamin D between and within the control and intervention groups.

  4. IL-6

    Time frame: 21 days

    baseline to end line in the concentration of serum IL-6 between and within the control and intervention groups.

  5. C-reactive protein

    Time frame: 21 days

    baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups.

  6. TNF-alpha

    Time frame: 21 days

    baseline to end line in the concentration of serum TNF-alpha between and within the control and intervention groups.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2021
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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