About this trial
This clinical study aims to gain a better understanding of how different forms of vitamin D are processed in the body in healthy individuals, pregnant women, and patients with various hormonal (endocrine) and kidney (renal) disorders. In the long term, this study may provide new insights that could how vitamin D is tested and interpreted in these groups.
Vitamin D has several important roles in the body, such as building strong bones and maintaining calcium balance in the blood. Most vitamin D in the blood circulation is attached/bound to a protein called "vitamin D binding protein" (VDBP), which makes it unavailable for the body to use. A much smaller portion circulates freely in the blood and this is called "free vitamin D". This free form can be directly used by the body.
When your doctor tests your vitamin D levels, this usually refers to total vitamin D (the sum of bound and free vitamin D). However, this total value may not give an accurate indication of your actual vitamin D status, since most of it (the bound part) cannot be used by the body. The purpose of this study is to examine whether "free vitamin D" is a better marker of vitamin D status and if the amount of free vitamin D differs between healthy people, pregnant women, and people with specific endocrine or kidney disorders.
Additionally, this study will look into vitamin D metabolism more detailed, and investigate what different forms of vitamin D exist, how the body processes these, and whether these forms may be related to certain endocrine or kidney conditions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
General
General
Disqualifiers
Below 18 years of age
Individuals incapable of providing informed consent
Cohort inclusion criteria
Obesity: BMI ≥ 25 kg/m2
Trial population
* Healthy controls: community sample * Other cohorts: recruited from UZ Leuven (Academic medical center/tertiairy care center)
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood draw for the laboratory assessment
Other interventionBlood draw for the laboratory assessment
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Direct measurement of free 25-hydroxyvitamin D3 levels
1\) Direct measurement of free 25-hydroxyvitamin D3, reported as concentration levels per cohort; * Reported at baseline * Reported as change versus healthy control group (all cohorts vs healthy control) * Reported as change within-cohort (Pregnancy and Primary Hyperparathyroidism).
Secondary outcomes
Calculation of free 25-hydroxyvitamin D3 levels
1\) Calculation of free 25-hydroxyvitamin D3, reported as concentration levels per cohort; * Reported at baseline * Reported as change versus healthy control group (all cohorts vs healthy control) * Reported as change within-cohort (Pregnancy and Primary Hyperparathyroidism).
Correlation of measured and calculated free 25-hydroxyvitamin D3 levels
Assessment of correlation between measured (Primary Outcome) and calculated (Secondary Outcome 1) free 25-hydroxyvitamin D3 levels
Laboratory assessment of vitamin D metabolite profile
Laboratory assessment of different vitamin D metabolites; * 25-hydroxyvitamin D3 * 3-epi-hydroxyvitamin D3 * 1(alpha).25-dihydroxyvitamin D3 * 1(beta).25-dihydroxyvitamin D3 * 3-epi-1.25-dihydroxyvitamin D3 * 24.25-dihydroxyvitamin D3 * 25-hydroxyvitamin D2 * 1.25-dihydroxyvitamin D2
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
KU Leuven
Collaborator