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

Vitamin D Serum Levels Clinical Trial

— VITAD/1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818594
• Other study ID #: VITAD-01-2018 Part 1
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: September 28, 2020

Study information

• Verified date: June 2021
• Source: Nutrition Institute, Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, skin colour and melanin index investigated .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 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.

Related Conditions & MeSH terms

• Vitamin D Serum Levels

Locations

Country	Name	City	State
Slovenia	Nutrition Institute, Ljubljana	Ljubljana

Sponsors (4)

Lead Sponsor	Collaborator
Nutrition Institute, Slovenia	Higher School of Applied Sciences (VIST), Slovenian Research Agency, Valens Int. d.o.o., Slovenija

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between vitamin D serum levels in winter and in summer season will be determined	Vitamin D serum level will be measured once in winter (December - January) and once in summer season (August-September) for each individual. The study will be performed over two consecutive years.	2 years
Secondary	Correlation of vitamin D serum levels with Fitzpatrick skin phototype	Fitzpatrick skin phototype will be determined using Fitzpatrick self-evaluation questionnaire in combination with expert assessment in August-September.	2 years
Secondary	Correlation of vitamin D serum levels with skin colour measured in CIE Lab colour space	Skin colour will be measured in CIE Lab colour space on inner and outer side of the upper arm. The measurement will be performed in August-September.	2 years
Secondary	Correlation of vitamin D serum levels with melanin index	Melanin index will be measured on inner and outer side of the upper arm. The measurement will be performed in August-September.	2 years