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OpenTrials
Completed

NCT Number: NCT06266702

Evaluation of a Nutritional Technology for Vitamin D Absorption

This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.

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Key information

Conditions

Nutrition, Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walsh University

North Canton, Ohio, 44720, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult participants (18-55 years of age)
  • Body mass index (BMI) <30 kg/m2
  • Males and nonpregnant, nonlactating females
  • Free of gastrointestinal disorders that my impact nutrient absorption in the small intestine, endocrine, hepatic, renal, or bone diseases

Exclusion criteria

  • Use of vitamin D or calcium supplements within 3 weeks prior to the Screening Visit.
  • Use of a tanning booth/lamp within 3 weeks prior to the Screening Visit.
  • Travel to sunny location within 3 weeks prior to the Screening Visit.
  • Consumption of more than 3 alcoholic drinks per day starting 48 hours before the Screening Visit.
  • Has an allergy or intolerance to any ingredient in the study product.
  • Participating in another study that has not been approved as a concomitant study by Abbott Nutrition.
  • Use of the following medications that may have interactions with vitamin D absorption or metabolism:
  • Aluminum-containing phosphate binders
  • Anticonvulsants
  • Atorvastatin
  • Calcipotriene
  • Cholestyramine
  • Cytochrome P-450 3A4 substrates
  • Digoxin
  • Diltiazem
  • Orlistat
  • Thiazide diuretics
  • Corticosteroids
  • Stimulant laxatives
  • Verapamil

Treatment and study plan

Experimental Oil with Phospholipids

Other

Consumed on white bread

Control Polyunsaturated Oil Blend

Other

Consumed on white bread

Primary outcomes

  1. Vitamin D Absorption

    Time frame: Time 0 to 24 Hours

    Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil

Secondary outcomes

  1. Vitamin D Absorption - Peak

    Time frame: Time 0 to 48 Hours

    Change in Peak serum for vitamin D in experimental versus control oil

  2. Vitamin D Absorption - AUC

    Time frame: Time 0 to 48 Hours

    Change in AUC for vitamin D in experimental versus control oil

Other outcomes

  1. Body Mass Index

    Time frame: Visit 1, Baseline Collection

    As calculated from height in cm and weight in kg

  2. Adverse Events

    Time frame: Study Day 1 to Study Day 7 up to 20 Days

    Participant reported adverse events during study duration

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Evaluation of a Lipid-based Nutritional Technology for Enhancing Vitamin D Absorption in Humans

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Jul 31, 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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