Evaluation of a Nutritional Technology for Vitamin D Absorption

Abbott

Status: Not yet enrolling

Conditions: Nutrition, Healthy

Treatments: Other: Control Polyunsaturated Oil Blend; Other: Experimental Oil with Phospholipids

Study type: Interventional

Funder types: Industry

Identifiers

NCT06266702

BL71

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 4 patient groups

Group 1A - High Vitamin D, Experimental Oil

Experimental group

Description:

High dose Vitamin D mixed with Experimental Oil

Treatment:

Other: Experimental Oil with Phospholipids

Group 1B - High Vitamin D, Control Oil

Active Comparator group

Description:

High Dose Vitamin D mixed with Control Oil

Treatment:

Other: Control Polyunsaturated Oil Blend

Group 2A - Low Vitamin D, Experimental Oil

Experimental group

Description:

Low dose Vitamin D mixed with Experimental Oil

Treatment:

Other: Experimental Oil with Phospholipids

Group 2B - Low Vitamin D, Control Oil

Active Comparator group

Description:

Low Dose Vitamin D mixed with Control Oil

Treatment:

Other: Control Polyunsaturated Oil Blend