Science & Research

Information About our Vitamin D Test Research

Vitamin D Testing Research Study

Study title: Demographic and Seasonal Evaluation (DACE-D) of 1,25-OH Vitamin D Levels in Canadians across Provinces and Territories

Participants: Canadians interested in participating in research and learning more about vitamin D levels in their demographic

Investigators: Dr. B. Mallard and Dr. N.A. Karrow

Contact information: E-mail: customersupport@immunoceutica.ca

Sponsor name: ImmunoCeutica Inc. (ICI) - Labs and Technologies

Conﬂict of interest: Dr. Mallard is a founder, majority shareholder, and Scientific Advisory Lead for ImmunoCeutica Inc. Dr. Karrow is a founder, shareholder, and the Chief Science Officer of ImmunoCeutica Inc.

Introduction: Vitamin D has been shown to have a signiﬁcant impact on overall health, beyond its role in calcium absorption and bone health. Vitamin D supports the immune system, dampens inﬂammation, promotes oral health, and helps prevent disorders such as diabetes and depression.

Recommended Dosage: The current recommended daily dose of vitamin D by Health Canada (1,000 IU) may not be sufficient to promote optimal levels of the biologically active form of vitamin D (1,25-OH Vitamin D), which is assessed by the presence of its precursor (25-OH vitamin D). Individual vitamin D levels are dependent on various factors such as age, Body Mass Index (BMI), skin tone, genetic makeup, diet, and sunlight exposure.

Individual Differences: Additionally, the inter-individual variability in blood vitamin D levels after supplementation poses a challenge to designing clinical studies with accurate outcomes. To address this issue, Huang & You developed a pharmacokinetic model to calculate vitamin D dosage based on prior knowledge of serum levels of 25-OH vitamin D7.

Additional Factors: However, this model does not account for other physiological factors and needs experimental validation. People who live in northern latitudes, such as Canada, are speciﬁcally prone to low vitamin D because of low-level light exposure, particularly in the winter months. Most Canadians are unaware of their vitamin D levels and may or may not be taking vitamin D. People supplementing with vitamin D often do not test their blood vitamin D levels, so they have no way to establish if their supplementation is helpful or not. Therefore, there is a crucial need to determine the levels of vitamin D in Canadians across various demographics and seasons.

References:

1. Ao T, Kikuta J, Ishii M. The Effects of Vitamin D on Immune System and Inﬂammatory Diseases. Biomolecules. 2021 Nov 3;11(11):1624.
2. Botelho J, Machado V, Proença L, Delgado AS, Mendes JJ. Vitamin D deﬁciency and oral health: a comprehensive review. Nutrients. 2020;12(5):1471.
3. Lemieux P, Weisnagel SJ, Caron AZ, et al. Effects of 6-month vitamin D supplementation on insulin sensitivity and secretion: a randomised, placebo-controlled trial. European Journal of Endocrinology. 2019;181(3):287-299.
4. Aless, Cuomo R, Giordano N, Goracci A, Fagiolini A. Depression and vitamin D deﬁciency: causality, assessment, and clinical practice implications. Neuropsychiatry. 2017;7(5):606–614.
5. Menon V, Kar SK, Suthar N, Nebhinani N. VitaminD and Depression: A Critical Appraisal of the Evidence and Future Directions. Indian J Psychol Med. 2020 Jan 6;42(1):11-21.
6. Lin L, Zhang L, Li C, Gai Z, Li Y. Vitamin D and vitamin D receptor: new insights in the treatment of hypertension. Curr Protein Pept Sci. 2019;20(10):984-995.
7. Huang Z, You T. Personalise vitamin D3 using physiologically based pharmacokinetic modelling. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):723-734.

Hypotheses: Canadians living at more northern latitudes will have a greater probability of having lower vitamin D, particularly in winter months. Appropriate seasonal testing and supplementation with vitamin D will bring vitamin D levels to optimal levels.

Objectives: The principal objective of this study is to develop a personalized seasonal vitamin D3 dosage regimen based on a research study questionnaire, as well as individual 25-OH vitamin D baseline values.

Vitamin D will be measured in a drop of blood either: 1 - through a home-based dried blood spot collection, ship-in-mail and ELISA test results, or 2 – through an on-site rapid vitamin D test kit designed to show test results within 20 minutes.

The study will assess the impact of different daily oral doses of vitamin D3 on the improvement of 25-OH vitamin D levels in the blood over time and correlate these results with factors such as BMI and age. Additionally, ICI's proprietary Vitamin D serum improvement model will be tested experimentally based on vitamin D regimen, BMI and age.

This research has the potential to contribute to a better understanding of the relationship between vitamin D and overall health of Canadians, as well as to inform personalized vitamin D supplementation for optimal health outcomes.

Study procedures: A small blood drop obtained by self-capillary puncture from participants will either be: 1 - spotted at home on a specialized paper membrane, allowed to air dry and shipped to the Immunoceutica lab to determine vitamin D by an Enzyme-Linked Immunosorbent Assay (ELISA)).

Risks and beneﬁts: There are no expected risks to participants from the donation of a capillary drop of blood utilizing a small lancet designed and approved for this purpose. It is similar to the skin prick test used to determine insulin values at home or in a health practitioner’s office.

The identities of study participants will not be revealed in any reports. However, the blinded results from the vitamin D questionnaire and the vitamin D test values will be analyzed to help inform future best practices for vitamin D supplementation of Canadians depending on age, BMI, and a variety of other predictive factors.

Unless required by law, any participant identifying information and blood sample will only be shared with a third party that has a conﬁdentiality agreements in place with ICI in a formalized collaboration, and they will further protect the identity of the participants. ICI conﬁrms that the blood sample will not be used for any other form of analysis, including DNA sequencing. The participants have the right to withdraw consent, and their data, at any time without giving reasons and without any penalty.

Participants will be informed of the test results showing the range of vitamin D level in their blood sample.

Compensation: There is no monetary compensation for being a participant in this study and there will be a cost applied to participants to cover the expenses associated with this research. This cost will be made know to the participant prior to enrolling in the study.

Independent institutional review board approval: This study has not been reviewed by a third party outside of ICI, but has been given thorough in-house review by the team of experienced researchers at ICI. The team of internal reviewers at ICI who have approved this study have designed, expedited and reported on hundreds of research studies over the course of their careers.

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