Vitamin D Deficiency
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTExperimental 1 (powdered supplement)
Active powdered ingredient (2,000 IU/d)
DIETARY_SUPPLEMENTExperimental 2 (oily supplement)
Active oily ingredient (2,000 IU/d)
Sponsors
Center for Health Sciences, Serbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 25(OH)D | Change from baseline 25(OH)D at 8 weeks | Serum levels of 25(OH)D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total calcium | Change from total calcium at 8 weeks | Serum levels of total calcium |
| Ionized calcium | Change from ionized calcium at 8 weeks | Serum levels of ionized calcium |
| Phosphorus | Change from phosphorus at 8 weeks | Serum levels of phosphorus |
| Magnesium | Change from magnesium at 8 weeks | Serum levels of magnesium |
Countries
Serbia
Contacts
Primary ContactSergej Ostojic, MD, PhD
Outcome results
None listed