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Recruiting NCT07317830

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

No phase Interventional Vitamin D Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental 1 (powdered supplement), Experimental 2 (oily supplement).
Who it may be relevant to
Registry conditions: Vitamin D Deficiency. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Serbia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 supplement Experimental 1 (powdered supplement)
    Active powdered ingredient (2,000 IU/d)
  • Dietary supplement Experimental 2 (oily supplement)
    Active oily ingredient (2,000 IU/d)

Primary outcome measures

  • 25(OH)D [Time frame: Change from baseline 25(OH)D at 8 weeks]
Secondary outcome measures (4)
  • Total calcium [Time frame: Change from total calcium at 8 weeks]
  • Ionized calcium [Time frame: Change from ionized calcium at 8 weeks]
  • Phosphorus [Time frame: Change from phosphorus at 8 weeks]
  • Magnesium [Time frame: Change from magnesium at 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Serbia · 1 center
  • Center for Health Sciences — Belgrade

Publications

  • Vieira EF, Souza S. Formulation Strategies for Improving the Stability and Bioavailability of Vitamin D-Fortified Beverages: A Review. Foods. 2022 Mar 16;11(6):847. doi: 10.3390/foods11060847. PMID 35327269
  • Dalek P, Drabik D, Wolczanska H, Forys A, Jagas M, Jedruchniewicz N, Przybylo M, Witkiewicz W, Langner M. Bioavailability by design - Vitamin D3 liposomal delivery vehicles. Nanomedicine. 2022 Jul;43:102552. doi: 10.1016/j.nano.2022.102552. Epub 2022 Mar 26. PMID 35346834
  • Borel P, Caillaud D, Cano NJ. Vitamin D bioavailability: state of the art. Crit Rev Food Sci Nutr. 2015;55(9):1193-205. doi: 10.1080/10408398.2012.688897. PMID 24915331

Identifiers

NCT: NCT07317830 · 302-27-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗