About this trial
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.
Eligibility criteria
Qualifiers
Adults aged 18 years and over
Serum 25(OH)D < 75 nmol/L
BMI 18.5 - 29.9 kg/m2
Free of clinically significant acute disorders and severe chronic diseases
Disqualifiers
Pregnancy of breast feeding
Underweight or obesity
History of any dietary supplement use within 8 weeks before screening
Medications that materially alter vitamin D metabolism or calcium balance
Trial design
Treatments tested in this trial
- Experimental 1 (powdered supplement)
- Experimental 2 (oily supplement)