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OpenTrials
Completed

NCT Number: NCT06010121

Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3

The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a traditional formulation.

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gdański Uniwersytet Medyczny

Gdansk, 80-211, Poland

About this study

The study will be randomized, cross-over, participants will be randomly assigned to one of the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group receiving vitamin D3 in liposomal formulation. The day before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will have their blood drawn. Then, after a wash-out period of 2 months, the groups will be switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks. Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women and men, 18-60 years old.
  • Signed informed consent.
  • No injuries or hospitalizations within the last 3 months.
  • No vitamin D supplementation for the 2 months prior to the study initiation.
  • Refraining for the period of the clinical trial from consuming foods additionally fortified with vitamin D and dietary supplements containing vitamin D
  • Refraining for the period of the clinical trial from the use of cosmetic therapies that use prolonged body illumination

Exclusion criteria

  • Unwilling to give consent
  • Injuries within the last 3 months
  • Obesity, BMI above 30
  • Bariatric surgery
  • Cystic fibrosis, celiac disease, Crohn's disease
  • Metabolic diseases
  • Drugs reducing cholesterol absorption, thiazide diuretics, glucocorticosteroids, anticonvulsants, calcium-containing preparations,
  • Planned prolonged exposure to sunlight during the study period

Treatment and study plan

Liposomal Vitamin D

Dietary Supplement

2000 IU of cholecalciferol in liposomal formulation

Traditional Vitamin D

Dietary Supplement

2000 IU of cholecalciferol in traditional formulation

Primary outcomes

  1. Level of 25-hydroxycholecalciferol

    Time frame: Baseline, 2 weeks, 4 weeks

    Comparison of the level of 25(OH)D3 achieved in the blood

Sponsors and collaborators

Lead sponsor

AronPharma Sp. z o. o.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2023
Registry last updated
Aug 25, 2023

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.