Evaluation of a Nutritional Technology for Vitamin D Absorption

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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

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

Trial contacts and locations

1

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Central trial contact

Kristen DeLuca

Data sourced from clinicaltrials.gov

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