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

Recruiting now · Not applicable

Conditions studied: Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT07317830

Run by

Center for Health Sciences, Serbia

People needed

20

Starts

2025-12-15

Expected to finish

2026-06-15

Last updated by the study team

2026-01-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Subjects with a history of medicine or alcohol abuse
• Abnormal values for lab clinical chemistry (> 2 SD)
• Unwillingness to return for follow-up analysis
• Participation in other clinical trials within 60 days prior to screening

Where it is running

• Center for Health Sciences — Belgrade, Serbia (enrolling)

Full record on ClinicalTrials.gov

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