Actively Recruiting
Free Fraction Vitamin D Measurements to Improve Understanding of Steroid Metabolism in Endocrine Disorders
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-08
930
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how different forms of vitamin D are processed in the body among healthy people, pregnant women, and patients with various hormonal (endocrine) and kidney (renal) disorders. The study aims to understand if measuring "free vitamin D"—the portion available for the body to use—is a better marker of vitamin D status compared to the usual total vitamin D measurement. This research may improve how vitamin D is tested and interpreted in these groups and explore relationships between vitamin D forms and specific endocrine or kidney conditions. Participants include healthy adults, people with obesity, those with chronic kidney disease, pregnant women, individuals with primary hyperparathyroidism, and those with complex calcium and phosphate balance disorders. Each group will provide blood samples at different time points; for example, pregnant women will have blood drawn four times during pregnancy and after delivery, while individuals with primary hyperparathyroidism will have blood drawn before and after surgery. Other groups will have a single blood draw for assessment. During the study, participants will undergo venous blood draws to measure free 25-hydroxyvitamin D3 levels and analyze vitamin D metabolites. Pregnant women and those with primary hyperparathyroidism will have samples collected at multiple time points to track changes. The research team will compare measured and calculated free vitamin D levels across all groups. The entire study involves no treatments but focuses on collecting data to better understand vitamin D metabolism and its role in these conditions.
CONDITIONS
Brief Title
Free Vitamin D and Steroid Metabolism in Endocrine Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or above
- Obesity cohort: BMI of 25 kg/m2 or higher
- Chronic Kidney Disease cohort: CKD stage 3a or higher (eGFR less than 60 mL/min/1.73m2)
- Pregnancy cohort: in the first trimester of pregnancy
- Primary hyperparathyroidism cohort: diagnosed and scheduled for parathyroidectomy at UZ Leuven
- Complex calcium and phosphate disorders cohort: diagnosed at UZ Leuven
You will not qualify if you...
- Younger than 18 years
- Unable to provide informed consent
- Healthy controls: BMI below 18 or above 25 kg/m2, pregnancy, chronic kidney disease, primary hyperparathyroidism, or taking vitamin D/calcium supplements
- Obesity cohort: chronic kidney disease, pregnancy, or primary hyperparathyroidism
- Chronic Kidney Disease cohort: BMI below 18 or above 30 kg/m2, pregnancy, or primary hyperparathyroidism
- Pregnancy cohort: BMI below 18 or above 30 kg/m2, chronic kidney disease, or primary hyperparathyroidism
- Primary hyperparathyroidism cohort: BMI below 18 or above 30 kg/m2, pregnancy, chronic kidney disease, or secondary hyperparathyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single timepoint or multiple timepoints depending on cohort
Participants undergo blood draws to measure free 25-hydroxyvitamin D3 levels and assess steroid metabolism according to their cohort assignment.
1 to 4 visits depending on cohort assignment
Duration - Up to 8 weeks post intervention or delivery depending on cohort
Participants may have follow-up blood draws after surgery or delivery to monitor vitamin D and steroid metabolism over time.
1 to 2 follow-up visits depending on cohort assignment
Trial Site Locations
Total: 1 location
1
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
N
Nick Narinx, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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