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| Name | Class |
|---|---|
| VIST - Faculty of Applied Sciences | OTHER |
| Slovenian Research Agency | OTHER |
| Valens Int. d.o.o., Slovenija | INDUSTRY |
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The efficiency of different vitamin D formulations in treating suboptimal vitamin D status in adult population will be determined. It will provide insights into the influence of formulation on vitamin D absorption.
A randomised controlled intervention trial will be conducted on at least 72 subjects (18-65 years) with suboptimal Vitamin D status. Subjects will be selected from a pool of subjects in Part 1 of the study, after completion of winter sampling.
Study subjects will be randomised into four study groups (at least 18 subjects per study group). Three different treatments will be compared with a control group, which will not receive any supplemental Vitamin D. The three tested Vitamin D preparations in the treatment groups will be (A) oil-based VALENS vitamin D; (B) water-based VALENS vitamin D; and (C) Vitamin D capsules with starch-adsorbed vitamin D (powder). All these products are commercially available. Prior to study, actual level of vitamin D will be determined using appropriate analytical method. The treatment will be with 1000 IU Vitamin D per day, for two months, in all three groups. Second serum vitamin D level will be determined on last day of the treatment, and compared with pre-treatment vitamin D level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oil-based vitamin D group | Experimental | Oil-based vitamin D, 1000 IU/day for 8 weeks |
|
| Water-based vitamin D group | Experimental | Water-based vitamin D, 1000 IU/day for 8 weeks |
|
| Vitamin D capsules group | Experimental | Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks |
|
| Control group | No Intervention | This group will receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oil-based vitamin D | Dietary Supplement | Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vitamin D serum concentration after 8 weeks of supplementation | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Žmitek, PhD | Researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition Institute, Ljubljana | Ljubljana | 1000 | Slovenia |
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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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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Water-based vitamin D | Dietary Supplement | Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks. |
|
| Vitamin D capsules | Dietary Supplement | Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks. |
|
| D009750 |
| Nutritional and Metabolic Diseases |