Status:
COMPLETED
Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2
Lead Sponsor:
Institute of Nutrition, Slovenia (Nutris)
Collaborating Sponsors:
VIST - Faculty of Applied Sciences
Slovenian Research Agency
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2019
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03810261
Start Date
January 8 2019
End Date
April 2 2019
Last Update
June 22 2021
Active Locations (1)
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1
Nutrition Institute, Ljubljana
Ljubljana, Slovenia, 1000