NCT06010121

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

August 21, 2023

Last Update Submit

August 24, 2023

Conditions

Bioavailability of Vitamin D

Keywords

Liposovit-DVitamin DCholecalciferol

Outcome Measures

Primary Outcomes (1)

  • Level of 25-hydroxycholecalciferol

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

    Baseline, 2 weeks, 4 weeks

Study Arms (2)

Liposomal Vitamin D

EXPERIMENTAL

Daily oral dose of liposomal vitamin D for 4 weeks

Dietary Supplement: Liposomal Vitamin D

Traditional Vitamin D

ACTIVE COMPARATOR

Daily oral dose of traditional vitamin D for 4 weeks

Dietary Supplement: Traditional Vitamin D

Interventions

Liposomal Vitamin DDIETARY_SUPPLEMENT

2000 IU of cholecalciferol in liposomal formulation

Liposomal Vitamin D
Traditional Vitamin DDIETARY_SUPPLEMENT

2000 IU of cholecalciferol in traditional formulation

Traditional Vitamin D

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gdański Uniwersytet Medyczny

Gdansk, 80-211, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 24, 2023

Study Start

February 17, 2023

Primary Completion

June 6, 2023

Study Completion

June 6, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)