Pharmacokinetics Evaluation of Vitamin D Formulations

NCT05209425 | Completed

• 1 other identifier: 2021-11-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate plasma concentrations of Vitamin D (25-hydroxyvitamin D; 1,25-dihydroxyvitamin D) of different Vitamin D formulations in healthy volunteers at two concentrations. Pharmacokinetic parameters (Serum 25(OH)D and 1,25(OH)2D ng/ml) are compared with those of a regular Vitamin D formulation and a new (microencapsulated) LipoMicel Vitamin D formulation. The secondary objective of this study is to evaluate safety blood parameters- The following blood parameters (serum levels) are checked: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT. In addition, mineral levels-such as calcium, magnesium and phosphorus, potassium and sodium-are measured before and at the end of the study.

Conditions

Vitamin D

Outcome Measures

Primary Outcomes (2)

• Evaluation of Vitamin D serum level: change of 1,25-Dihydroxyvitamin D

  Venous blood samples are collected to measure concentrations of 1,25-Dihydroxyvitamin D

  at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).

• Evaluation of Vitamin D serum level: change of 25-Hydroxyvitamin D

  Venous blood samples are collected to measure concentrations of 25-Hydroxyvitamin D

  at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment).

Secondary Outcomes (11)

• Safety blood work evaluation - change of aspartate aminotransferase (AST)

  at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).

• Safety blood work evaluation - change of alanine aminotransferase (ALT)

  at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).

• Safety blood work evaluation - change of alkaline phosphatase

  at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).

• Safety blood work evaluation - change of bilirubin

  at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).

• Safety blood work evaluation - change of gamma-glutamyl transferase (GGT)

  at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).

Study Arms (4)

Regular Vitamin D3 1000IU

ACTIVE COMPARATOR

The first group receives regular Vitamin D3 1000IU

Dietary Supplement: Vitamin D3

Microencapsulated Vitamin D3 1000IU

ACTIVE COMPARATOR

The second group receives microencapsulated Vitamin D3 1000IU

Dietary Supplement: Vitamin D3

Regular Vitamin D3 2500IU

ACTIVE COMPARATOR

The third group receives regular Vitamin D3 2500IU

Dietary Supplement: Vitamin D3

Microencapsulated Vitamin D3 2500IU

ACTIVE COMPARATOR

The fourth group receives microencapsulated Vitamin D3 2500IU

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Participants are randomly divided into 4 groups. The first group receives regular Vitamin D3 (1000IU), the second receives microencapsulated D3 (1000IU), the third group receives regular Vitamin D3 (2500IU), the fourth receives microencapsulated D3 (2500 IU). Plasma concentrations of Vitamin D (D3, 25(OH)D3 and D2) are measured at baseline-before treatment start (day 0), during treatment (day 14) and at end of treatment (day 30). After the end of supplementation, blood vitamin D concentrations are checked again at day 45 and day 60.

Microencapsulated Vitamin D3 1000IU; Microencapsulated Vitamin D3 2500IU; Regular Vitamin D3 1000IU; Regular Vitamin D3 2500IU

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 21 and 65 years; avoid consumption of any additional food supplements containing vitamin D; avoid use of tanning beds or other artificial UVB sources.
• Participants must complete an online questionnaire on their medical history, weight, height, lifestyle (smoking, exercising etc.) and dietary habits relating to food rich in vitamin D, including other dietary supplementations.

You may not qualify if:

• use of vitamin D, calcium, magnesium, fish oil, or omega 3 fatty acids supplements; history of acute or chronic illness (such as gastrointestinal, liver and kidney disorders, osteoporosis …); pregnancy or lactation.

Sponsors & Collaborators

• Factors Group of Nutritional Companies Inc.: lead

Study Sites (1)

Natural Factors

Coquitlam, British Columbia, V3K 6Y2, Canada

Location

Related Publications (1)

• Solnier J, Chang C, Zhang Y, Kuo YC, Du M, Roh YS, See J, Brix J, Gahler RJ, Green T, Wood S. A Comparison and Safety Evaluation of Micellar versus Standard Vitamin D3 Oral Supplementation in a Randomized, Double-Blind Human Pilot Study. Nutrients. 2024 May 22;16(11):1573. doi: 10.3390/nu16111573.

  PMID: 38892507 DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel, randomized blinded study

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 26, 2022
• Study Start: January 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CA (1)