Microencapsulated Vitamin D3 2500IU for Vitamin D

Natural Factors, Coquitlam, Canada
Vitamin DVitamin D3 - DietarySupplement
Eligibility
21 - 65
All Sexes

Study Summary

This trial is testing two different concentrations of vitamin D to see which is more effective. They are also testing a new microencapsulated LipoMicel Vitamin D formulation to see if it is more effective than the regular vitamin D formulation.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 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).

Day 60
Safety blood work evaluation - change of C Reactive Protein (CRP)
Safety blood work evaluation - change of alanine aminotransferase (ALT)
Safety blood work evaluation - change of alkaline phosphatase
Safety blood work evaluation - change of aspartate aminotransferase (AST)
Safety blood work evaluation - change of bilirubin
Safety blood work evaluation - change of creatinine
Safety blood work evaluation - change of gamma-glutamyl transferase (GGT)
Safety blood work evaluation - change of mineral levels such as calcium
Safety blood work evaluation - change of mineral levels such as magnesium
Safety blood work evaluation - change of mineral levels such as phosphate
Safety blood work evaluation - change of mineral levels such as sodium
Day 45
Body Weight Changes
Evaluation of Vitamin D serum level: change of 25-Hydroxyvitamin D

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Microencapsulated Vitamin D3 2500IU
1 of 4
Microencapsulated Vitamin D3 1000IU
1 of 4
Regular Vitamin D3 2500IU
1 of 4
Regular Vitamin D3 1000IU
1 of 4

Active Control

50 Total Participants · 4 Treatment Groups

Primary Treatment: Microencapsulated Vitamin D3 2500IU · No Placebo Group · N/A

Microencapsulated Vitamin D3 2500IU
DietarySupplement
ActiveComparator Group · 1 Intervention: Vitamin D3 · Intervention Types: DietarySupplement
Microencapsulated Vitamin D3 1000IU
DietarySupplement
ActiveComparator Group · 1 Intervention: Vitamin D3 · Intervention Types: DietarySupplement
Regular Vitamin D3 2500IU
DietarySupplement
ActiveComparator Group · 1 Intervention: Vitamin D3 · Intervention Types: DietarySupplement
Regular Vitamin D3 1000IU
DietarySupplement
ActiveComparator Group · 1 Intervention: Vitamin D3 · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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).

Who is running the clinical trial?

Factors Group of Nutritional Companies Inc.Lead Sponsor
4 Previous Clinical Trials
154 Total Patients Enrolled

Eligibility Criteria

Age 21 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Are we still looking for more participants for this research?

"That is correct, the online information from clinicaltrials.gov says that this study is currently enrolling patients. This trial was first posted on January 1st, 2022 and has since been edited August 2nd of the same year. They are looking for 50 individuals total between 1 site." - Anonymous Online Contributor

Unverified Answer

Is this research project enrolling adults who are still under the age of majority?

"This study's eligibility requirements state that patients must be between 21-65 years old. If a potential patient does not meet this age criterion, there are two other trials they could possibly enroll in." - Anonymous Online Contributor

Unverified Answer

What are the main goals of this clinical trial?

"According to the study sponsor, Factors Group of Nutritional Companies Inc., the primary outcome metric for this trial is change in serum vitamin D levels over time. This will be measured at baseline (before treatment), and then again at days 5, 10, 15 (during treatment), day 30 (end of treatment), as well as 45 and 60 post-treatment. Additionally, this clinical trial will also measure secondary outcomes including changes in creatinine and aminotransferase levels before and after the intervention." - Anonymous Online Contributor

Unverified Answer

How can I sign up for the chance to participate in this experiment?

"This study is looking for 50 individuals who are currently taking vitamin D supplements and meet the following criteria: 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." - Anonymous Online Contributor

Unverified Answer

How many patients are eligible for this clinical trial?

"Yes, the information on clinicaltrials.gov points out that this clinical trial is presently searching for patients. The study was first posted on 1/1/2022 and was most recently edited on 8/2/2022. The trial is enrolling 50 patients across 1 sites" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.