Actively Recruiting
Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults
Led by Center for Health Sciences, Serbia · Updated on 2026-01-05
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized controlled superiority pilot trial will evaluate the efficacy of two vitamin D3 formulations administered over eight weeks in adults with subclinical or clinical vitamin D deficiency. The study will compare changes in serum 25-hydroxyvitamin D concentrations between formulations, as well as the proportion of participants who will achieve vitamin D sufficiency. Both formulations are expected to improve vitamin D status, with the hypothesis that one formulation will demonstrate superior bioavailability, resulting in greater and faster increases in circulating 25-hydroxyvitamin D. The findings will provide preliminary evidence to inform formulation selection and dosing strategies for correcting vitamin D deficiency and will support the design of larger, confirmatory trials.
CONDITIONS
Official Title
Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and over
- Serum 25(OH)D less than 75 nmol/L
- Body mass index (BMI) between 18.5 and 29.9 kg/m2
- Free of clinically significant acute disorders and severe chronic diseases
- No planned travel to high-UV destinations or tanning bed use during the trial
- Willing to avoid non-study vitamin D supplements
- Able to give written informed consent and comply with study visits
- Submitted informed consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Underweight or obesity
- Use of any dietary supplements within 8 weeks before screening
- Use of medications that affect vitamin D metabolism or calcium balance
- History of medicine or alcohol abuse
- Abnormal laboratory clinical chemistry values (greater than 2 standard deviations)
- Unwillingness to return for follow-up analysis
- Participation in other clinical trials within 60 days prior to screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Center for Health Sciences
Belgrade, Serbia, 11000
Actively Recruiting
Research Team
S
Sergej Ostojic, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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