Status:

COMPLETED

Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1

Lead Sponsor:

Institute of Nutrition, Slovenia (Nutris)

Collaborating Sponsors:

VIST - Faculty of Applied Sciences

Slovenian Research Agency

Conditions:

Vitamin D Serum Levels

Eligibility:

All Genders

18-65 years

Brief Summary

Seasonal variations in vitamin D status will be determined on a cohort of Slovenian adults using longitudinal study design, and association between vitamin D status and different Caucasian phototypes,...

Eligibility Criteria

Inclusion

  • 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 hihg-fat 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 :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 28 2020

Estimated Enrollment :

338 Patients enrolled

Trial Details

Trial ID

NCT03818594

Start Date

January 8 2019

End Date

September 28 2020

Last Update

June 18 2021

Active Locations (1)

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1

Nutrition Institute, Ljubljana

Ljubljana, Slovenia, 1000