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

What this Trial Is About

Researchers are evaluating the effects of two different vitamin D3 supplement forms in adults aged 18 to 80 years who have either subclinical or clinical vitamin D deficiency. This randomized controlled superiority pilot trial aims to compare how each formulation changes blood levels of 25-hydroxyvitamin D over eight weeks. The study will assess which formulation raises vitamin D levels more effectively and quickly. The findings will help guide future studies and dosing recommendations for correcting vitamin D deficiency. Participants will be randomly assigned to receive either 2,000 IU per day of vitamin D3 in powdered form or the same dose in an oily form. Both supplements are dietary supplements and will be taken daily for a total of eight weeks. The trial uses triple masking to ensure unbiased results. No placebo group is included, as both groups receive active vitamin D3 formulations. During the study, participants will undergo blood tests to measure changes in 25-hydroxyvitamin D, total calcium, ionized calcium, phosphorus, and magnesium at baseline and after eight weeks. Researchers will monitor adherence and any health changes throughout the trial. Participants must avoid other vitamin D supplements and tanning activities during the study. The total participation time is about eight weeks, with follow-up visits to assess the effects of the supplementation.

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