The Effects of Eight Weeks of Supplementation With Two Vitamin D₃ Formulations in Adults With Subclinical and Clinical Vitamin D Deficiency: A Randomized Controlled Superiority Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
Serbia
Center for Health Sciences
RECRUITING
Belgrade
Contact Information
Primary
Sergej Ostojic, MD, PhD
sergej.ostojic@chess.edu.rs
+381112643242
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 20
Treatments
Experimental: Experimental 1
2,000 IU of active ingredient (powder) per day
Active_comparator: Experimental 2
2,000 IU of active ingredient (oil) per day
Related Therapeutic Areas
Sponsors
Leads: Center for Health Sciences, Serbia

This content was sourced from clinicaltrials.gov