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

Vitamin D Deficiency Clinical Trial

— VITAD/2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810261
• Other study ID #: VITAD-01-2018 Part 2
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: April 2, 2019

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Oil-based vitamin D
Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.
• Water-based vitamin D
Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.
• Vitamin D capsules
Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.

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	Change in vitamin D serum concentration after 8 weeks of supplementation		8 weeks

External Links

•   Study results: Efficiency of Vitamin D Supplementation in Healthy Adults is Associated with Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level