Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2

Study Overview
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Brief Summary
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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.

Official Title
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Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Oil-based vitamin D
* Dietary Supplement: Water-based vitamin D
* Dietary Supplement: Vitamin D capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vitamin D suboptimal status Signed Informed consent form (ICF), Caucasian race Age between 18 and 65 years at the time of the signature of Informed consent form (ICF), Willingness to avoid a consumption of any food supplements containing Vitamin D during the study, except the ones prescribed by the study researchers, and to avoid use of solarium or other artificial UVB sources Willingness to follow all study procedures Exclusion Criteria: Pregnancy or breastfeeding, Known or suspected allergy to any ingredient of the tested products in Part 2, Pronounced avoidance of sunshine (eg reporting of allergy to the sun) Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in last three months prior to inclusion, Special dietary habits used by a small part of the population (veganism, low-carb high-fat (LCHF) diet, caloric restriction diet, note: vegetarians are not excluded) Diets prescribed by the medical profession Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone diseases, skin diseases Other diseases and conditions that affect the absorption and synthesis of vitamin D Exposure to stronger sunlight in the last three months prior to engaging in a survey (travel to countries with stronger sunshine, use of solarium), The consumption of margarine or plant substitutes for milk / milk products several times a day, as these foods are most often enriched with vitamin D, Visiting the solarium in the last three months before joining the survey, Mental incapacity that precludes adequate understanding or cooperation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oil-based vitamin D group<br>Oil-based vitamin D, 1000 IU/day for 8 weeks | Dietary Supplement: Oil-based vitamin D<br>* Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.<br>|
| Experimental: Water-based vitamin D group<br>Water-based vitamin D, 1000 IU/day for 8 weeks | Dietary Supplement: Water-based vitamin D<br>* Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.<br>|
| Experimental: Vitamin D capsules group<br>Vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks | Dietary Supplement: Vitamin D capsules<br>* Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.<br>|
| No Intervention: Control group<br>This group will receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vitamin D serum concentration after 8 weeks of supplementation |  | 8 weeks |