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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Experimental 1 (powdered supplement)

    Dietary supplement

    Active powdered ingredient (2,000 IU/d)

  • Experimental 2 (oily supplement)

    Dietary supplement

    Active oily ingredient (2,000 IU/d)

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Experimental 1Experimental treatment 1 intervention
Group B: Experimental 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

25(OH)D

Serum levels of 25(OH)D

Time frame
Change from baseline 25(OH)D at 8 weeks

Secondary outcomes

1

Total calcium

Serum levels of total calcium

Time frame
Change from total calcium at 8 weeks
2

Ionized calcium

Serum levels of ionized calcium

Time frame
Change from ionized calcium at 8 weeks
3

Phosphorus

Serum levels of phosphorus

Time frame
Change from phosphorus at 8 weeks
4

Magnesium

Serum levels of magnesium

Time frame
Change from magnesium at 8 weeks

Other outcomes

Sponsors and contacts

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