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
This trial accepts healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Experimental 1 (powdered supplement)
Dietary supplementActive powdered ingredient (2,000 IU/d)
Experimental 2 (oily supplement)
Dietary supplementActive oily ingredient (2,000 IU/d)
Treatment groups
Trial outcomes
Primary outcomes
25(OH)D
Serum levels of 25(OH)D
Secondary outcomes
Total calcium
Serum levels of total calcium
Ionized calcium
Serum levels of ionized calcium
Phosphorus
Serum levels of phosphorus
Magnesium
Serum levels of magnesium
Sponsors and contacts
Click on the lead sponsor to view all of their trials.