Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCenter for Health Sciences, Serbia

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)

Treatment groups

20 Participants
are divided into 2 treatment groups