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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | 2,000 IU of active ingredient (powder) per day |
|
| Experimental 2 | Active Comparator | 2,000 IU of active ingredient (oil) per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental 1 (powdered supplement) | Dietary Supplement | Active powdered ingredient (2,000 IU/d) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 25(OH)D | Serum levels of 25(OH)D | Change from baseline 25(OH)D at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total calcium | Serum levels of total calcium | Change from total calcium at 8 weeks |
| Ionized calcium | Serum levels of ionized calcium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergej Ostojic, MD, PhD | Contact | +381112643242 | sergej.ostojic@chess.edu.rs |
| Name | Affiliation | Role |
|---|---|---|
| Sergej Ostojic, MD, PhD | University of California, Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Health Sciences | Recruiting | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35327269 | Background | 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. | |
| 35346834 | Background | 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. |
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Data obtained through this study may be provided to qualified researchers with academic interest in vitamin D. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Only qualified researchers with academic interest in vitamin D research
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| Experimental 2 (oily supplement) | Dietary Supplement | Active oily ingredient (2,000 IU/d) |
|
| Change from ionized calcium at 8 weeks |
| Phosphorus | Serum levels of phosphorus | Change from phosphorus at 8 weeks |
| Magnesium | Serum levels of magnesium | Change from magnesium at 8 weeks |
| 24915331 | Background | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |