Evaluation of a Nutritional Technology for Vitamin D Absorption

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Other: Experimental Oil with Phospholipids; Other: Control Polyunsaturated Oil Blend

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen DeLuca; Phone Number: 16145653522; Email: kristen.deluca@abbott.com

Study Locations

• United States
  • Ohio
    • North Canton, Ohio, United States, 44720
      • Walsh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1A - High Vitamin D, Experimental Oil; High dose Vitamin D mixed with Experimental Oil	Other: Experimental Oil with Phospholipids; Consumed on white bread
Active Comparator: Group 1B - High Vitamin D, Control Oil; High Dose Vitamin D mixed with Control Oil	Other: Control Polyunsaturated Oil Blend; Consumed on white bread
Experimental: Group 2A - Low Vitamin D, Experimental Oil; Low dose Vitamin D mixed with Experimental Oil	Other: Experimental Oil with Phospholipids; Consumed on white bread
Active Comparator: Group 2B - Low Vitamin D, Control Oil; Low Dose Vitamin D mixed with Control Oil	Other: Control Polyunsaturated Oil Blend; Consumed on white bread

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D Absorption	Change in area under the curve (AUC) of serum vitamin D for low dose in experimental versus control oil	Time 0 to 24 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D Absorption - Peak	Change in Peak serum for vitamin D in experimental versus control oil	Time 0 to 48 Hours
Vitamin D Absorption - AUC	Change in AUC for vitamin D in experimental versus control oil	Time 0 to 48 Hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	As calculated from height in cm and weight in kg	Visit 1, Baseline Collection
Adverse Events	Participant reported adverse events during study duration	Study Day 1 to Study Day 7 up to 20 Days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Steve Hertzler, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BL71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No