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

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

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.

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