Clinical trial NCT03810261: Challenges in Achieving Adequate Vitamin D Status in the Adult Population/ Part 2
Official title: Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: VIST - Faculty of Applied Sciences
name: Slovenian Research Agency
name: Valens Int. d.o.o., Slovenija
First posted: 2019-01-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in vitamin D serum concentration after 8 weeks of supplementation
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Nutrition Institute, Ljubljana
Study officials:
affiliation: Researcher
name: Katja Žmitek, PhD
role: PRINCIPAL_INVESTIGATOR
References: