Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT07317830

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

Led by Center for Health Sciences, Serbia · Updated on 2026-01-05

20

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and over
  • Serum 25(OH)D less than 75 nmol/L
  • Body mass index (BMI) between 18.5 and 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
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Underweight or obesity
  • Use of any dietary supplements within 8 weeks before screening
  • Use of medications that affect vitamin D metabolism or calcium balance
  • History of medicine or alcohol abuse
  • Abnormal laboratory clinical chemistry values (greater than 2 standard deviations)
  • Unwillingness to return for follow-up analysis
  • Participation in other clinical trials within 60 days prior to screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Center for Health Sciences

Belgrade, Serbia, 11000

Actively Recruiting

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Research Team

S

Sergej Ostojic, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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