Free Vitamin D and Steroid Metabolism in Endocrine Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood draw for the laboratory assessment

    Other intervention

    Blood draw for the laboratory assessment

Treatment groups

930 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Healthy Controls1 intervention
Group B: Obesity1 intervention
Group C: Chronic Kidney Disease1 intervention
Group D: Pregnancy1 intervention
Group E: Primary Hyperparathyroidism1 intervention
Group F: Complex calcium/phosphate disorders1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
- 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)

Secondary outcomes

1

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).

Time frame
- 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)
2

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

Time frame
- 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)
3

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

Time frame
- 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)

Other outcomes

Sponsors and contacts

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