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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls |
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| Obesity |
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| Chronic Kidney Disease |
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| Pregnancy |
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| Primary Hyperparathyroidism |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw for the laboratory assessment | Other | Blood draw for the laboratory assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| Direct measurement of free 25-hydroxyvitamin D3 levels | 1) Direct measurement of free 25-hydroxyvitamin D3, reported as concentration levels per cohort;
| - Baseline (all cohorts) - Baseline (trimester 1, week 1-12) , trimester 2 (week 13-27), trimester 3 (week 28-40) and 4-6 weeks after delivery (Pregnancy) - Baseline, perioperative and 4-8 weeks after parathyroidectomy (Primary Hyperparathyroidism) |
| Measure | Description | Time Frame |
|---|---|---|
| Calculation of free 25-hydroxyvitamin D3 levels | 1) Calculation of free 25-hydroxyvitamin D3, reported as concentration levels per cohort;
| - Baseline (all cohorts) - Baseline (trimester 1, week 1-12) , trimester 2 (week 13-27), trimester 3 (week 28-40) and 4-6 weeks after delivery (Pregnancy) - Baseline, perioperative and 4-8 weeks after parathyroidectomy (Primary Hyperparathyroidism) |
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General inclusion Criteria:
- 18 years or above
General exclusion Criteria:
Cohort inclusion criteria
Cohort exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nick Narinx, MD | Contact | +3216348516 | nick.narinx@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Leen Antonio, MD, PhD | University Hospitals Leuven, Department of Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Sampling by venous blood draw;
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| Complex calcium/phosphate disorders |
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| 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 | - Baseline (all cohorts) - Baseline (trimester 1, week 1-12) , trimester 2 (week 13-27), trimester 3 (week 28-40) and 4-6 weeks after delivery (Pregnancy) - Baseline, perioperative and 4-8 weeks after parathyroidectomy (Primary Hyperparathyroidism) |
| Laboratory assessment of vitamin D metabolite profile | Laboratory assessment of different vitamin D metabolites;
| - Baseline (all cohorts) - Baseline (trimester 1, week 1-12) , trimester 2 (week 13-27), trimester 3 (week 28-40) and 4-6 weeks after delivery (Pregnancy) - Baseline, perioperative and 4-8 weeks after parathyroidectomy (Primary Hyperparathyroidism) |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |